ClinicalTrials.gov

History of Changes for Study: NCT02626455
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4)
Latest version (submitted September 23, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 8, 2015 Nothing (earliest Version on record)
2 January 8, 2016
Recruitment Status
, Study Status, Contacts/Locations and Eligibility
3 February 9, 2016 Study Status and Contacts/Locations
4 March 10, 2016 Study Status, Contacts/Locations and Study Identification
5 April 12, 2016 Contacts/Locations and Study Status
6 May 6, 2016 Study Status and Contacts/Locations
7 June 8, 2016 Study Status and Contacts/Locations
8 July 13, 2016 Contacts/Locations and Study Status
9 July 26, 2016 Contacts/Locations and Study Status
10 August 25, 2016 Contacts/Locations and Study Status
11 September 26, 2016 Study Status and Contacts/Locations
12 October 26, 2016 Outcome Measures, Study Status, Study Description, Contacts/Locations, Eligibility and Study Design
13 November 29, 2016 Contacts/Locations, Study Status and Eligibility
14 December 30, 2016 Study Status and Contacts/Locations
15 February 9, 2017 Contacts/Locations and Study Status
16 March 10, 2017 Contacts/Locations, Study Status, Outcome Measures and Eligibility
17 April 11, 2017 Contacts/Locations and Study Status
18 May 12, 2017 Contacts/Locations, Oversight and Study Status
19 June 13, 2017 Contacts/Locations and Study Status
20 July 17, 2017 Contacts/Locations and Study Status
21 August 17, 2017 Contacts/Locations and Study Status
22 September 14, 2017 Contacts/Locations and Study Status
23 October 13, 2017 Contacts/Locations and Study Status
24 November 10, 2017 Contacts/Locations, Study Description, Study Status, Eligibility and Study Design
25 December 12, 2017 Contacts/Locations and Study Status
26 January 11, 2018 Contacts/Locations and Study Status
27 February 12, 2018 Contacts/Locations and Study Status
28 March 13, 2018 Contacts/Locations, Study Status and Study Design
29 April 12, 2018 Contacts/Locations and Study Status
30 May 8, 2018 Contacts/Locations and Study Status
31 June 4, 2018 Contacts/Locations and Study Status
32 July 3, 2018 Contacts/Locations and Study Status
33 July 19, 2018 Contacts/Locations and Study Status
34 August 13, 2018 Contacts/Locations and Study Status
35 August 31, 2018 Contacts/Locations and Study Status
36 September 12, 2018 Contacts/Locations and Study Status
37 October 10, 2018 Contacts/Locations and Study Status
38 November 8, 2018 Outcome Measures, Contacts/Locations, Eligibility, Study Design, Study Description and Study Status
39 December 6, 2018 Contacts/Locations and Study Status
40 January 2, 2019 Contacts/Locations and Study Status
41 February 1, 2019 Contacts/Locations and Study Status
42 February 28, 2019 Contacts/Locations and Study Status
43 March 27, 2019 Contacts/Locations and Study Status
44 May 6, 2019 Contacts/Locations and Study Status
45 June 4, 2019 Contacts/Locations and Study Status
46 July 3, 2019 Contacts/Locations and Study Status
47 August 2, 2019 Study Status and Contacts/Locations
48 August 30, 2019 Contacts/Locations and Study Status
49 September 23, 2019 Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Description
Comparison Format:

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Changes (Side-by-Side) for Study: NCT02626455
August 2, 2019 (v47) -- August 30, 2019 (v48)

Changes in: Contacts/Locations and Study Status

Study Identification
Unique Protocol ID: 17833 17833
Brief Title: Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4)Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4)
Official Title: A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Secondary IDs: 2015-001088-38 [EudraCT Number]2015-001088-38 [EudraCT Number]
Study Status
Record Verification: August 2019 August 2019
Overall Status: Recruiting Recruiting
Study Start: January 6, 2016 January 6, 2016
Primary Completion: September 30, 2021 [Anticipated ] September 30, 2021 [Anticipated ]
Study Completion: December 31, 2024 [Anticipated ] December 31, 2024 [Anticipated ]
First Submitted: November 3, 2015 November 3, 2015
First Submitted that
Met QC Criteria:
December 8, 2015 December 8, 2015
First Posted: December 10, 2015 [Estimate ] December 10, 2015 [Estimate ]
Last Update Submitted that
Met QC Criteria:
August 2, 2019 August 30, 2019
Last Update Posted: August 5, 2019 [Actual ] September 2, 2019 [Estimate ]
Sponsor/Collaborators
Sponsor: Bayer Bayer
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Data Monitoring: Yes Yes
Study Description
Brief Summary: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents. The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
Detailed Description:

Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response or progression within 6 months of the last date of rituximab administration, including rituximab maintenance). This study will be composed of two parts: Safety run-in and phase III part.

The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study started with the determined recommended dose of copanlisib of 60 mg in combination with R-B.

A maximum of 24 patients will take part in the safety run-in part of this study. In the phase III part approximately 520 patients will be randomly assigned to blinded treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP.

Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response or progression within 6 months of the last date of rituximab administration, including rituximab maintenance). This study will be composed of two parts: Safety run-in and phase III part.

The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study started with the determined recommended dose of copanlisib of 60 mg in combination with R-B.

A maximum of 24 patients will take part in the safety run-in part of this study. In the phase III part approximately 520 patients will be randomly assigned to blinded treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP.

Conditions
Conditions: Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin
Keywords: Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma
Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: QuadrupleParticipant, Care Provider, Investigator, Outcomes AssessorQuadrupleParticipant, Care Provider, Investigator, Outcomes Assessor
Allocation: RandomizedRandomized
Enrollment: 544 [Anticipated ] 544 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
Experimental: Copanlisib + R-B or R-CHOP / Arm 1
Combination of copanlisib with standard immunochemotherapy (rituximab and bendamustine) [R-B] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP] (safety run-in and phase III)
Drug: Copanlisib (BAY80-6946)
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days.
Drug: Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Drug: Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Drug: Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Placebo Comparator: Placebo + R-B or R-CHOP / Arm 2
Combination of placebo and R-B or R-CHOP (phase III only)
Drug: Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
Drug: Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Drug: Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Drug: Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Drug: Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Outcome Measures
Primary Outcome Measures:
1. Safety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse events
At Cycle 1: 21 days or 28 days
Safety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse events
At Cycle 1: 21 days or 28 days
2. Phase III_Evaluation whether copanlisib in combination with standard immunochemotherapy is superior to placebo and standard immunochemotherapy assessed by the prolongation of progression free survival (PFS)
Progression free survival is defined as the time (in days) from randomization to disease progression or death from any cause (if no progression documented).

[Time Frame: Up to 52 months ]
Phase III_Evaluation whether copanlisib in combination with standard immunochemotherapy is superior to placebo and standard immunochemotherapy assessed by the prolongation of progression free survival (PFS)
Progression free survival is defined as the time (in days) from randomization to disease progression or death from any cause (if no progression documented).

[Time Frame: Up to 52 months ]
Secondary Outcome Measures:
3. Safety run-in_Best Overall Response (BOR)
After Cycle 1: Up to 12 months
Safety run-in_Best Overall Response (BOR)
After Cycle 1: Up to 12 months
4. Safety run-in_Number of participants with treatment-emergent adverse events
Up to 13 months
Safety run-in_Number of participants with treatment-emergent adverse events
Up to 13 months
5. Phase III_Objective tumor response rate (ORR)
Proportion of patients who have a best overall response over the whole duration of the study (i.e. up to time of analysis of PFS) of complete response (CR), very good partial response (VGPR), partial response (PR) or minor response (MR).

[Time Frame: Up to 52 months ]
Phase III_Objective tumor response rate (ORR)
Proportion of patients who have a best overall response over the whole duration of the study (i.e. up to time of analysis of PFS) of complete response (CR), very good partial response (VGPR), partial response (PR) or minor response (MR).

[Time Frame: Up to 52 months ]
6. Phase III_Duration of tumor response (DOR)
Time (in days) from first observed tumor response (complete response [CR], very good partial response [VGPR], partial response [PR], or minor response [MR]) until PD or death from any cause, whichever is earlier. DOR will only be analyzed for patients with at least one CR, VGPR, PR, or MR.

[Time Frame: Up to 52 months ]
Phase III_Duration of tumor response (DOR)
Time (in days) from first observed tumor response (complete response [CR], very good partial response [VGPR], partial response [PR], or minor response [MR]) until PD or death from any cause, whichever is earlier. DOR will only be analyzed for patients with at least one CR, VGPR, PR, or MR.

[Time Frame: Up to 52 months ]
7. Phase III_Complete tumor response rate (CRR)
Proportion of patients who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).

[Time Frame: Up to 52 months ]
Phase III_Complete tumor response rate (CRR)
Proportion of patients who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).

[Time Frame: Up to 52 months ]
8. Phase III_Time to tumor progression (TTP)
Time from randomization to PD or death related to PD, whichever is earlier.

[Time Frame: Up to 52 months ]
Phase III_Time to tumor progression (TTP)
Time from randomization to PD or death related to PD, whichever is earlier.

[Time Frame: Up to 52 months ]
9. Phase III_Time to next anti-lymphoma treatment (TTNT)
Time from stop of study medication to start of new anti-lymphoma therapy.

[Time Frame: Up to 52 months ]
Phase III_Time to next anti-lymphoma treatment (TTNT)
Time from stop of study medication to start of new anti-lymphoma therapy.

[Time Frame: Up to 52 months ]
10. Phase III_Overall survival (OS)
The time (in days) from randomization until death from any cause.

[Time Frame: Up to 5 years after last patient´s first treatment ]
Phase III_Overall survival (OS)
The time (in days) from randomization until death from any cause.

[Time Frame: Up to 5 years after last patient´s first treatment ]
11. Phase III_Time to improvement in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire

Time to improvement in disease-related physical symptoms (DRS-P) is defined as time from randomization to first increase in DRS-P score of at least 3 points from baseline before tumor progression. Will be evaluated for patients with a baseline DRS-P score of 30 points or less.

The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.



[Time Frame: Up to 52 months ]
Phase III_Time to improvement in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire

Time to improvement in disease-related physical symptoms (DRS-P) is defined as time from randomization to first increase in DRS-P score of at least 3 points from baseline before tumor progression. Will be evaluated for patients with a baseline DRS-P score of 30 points or less.

The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.



[Time Frame: Up to 52 months ]
12. Phase III_Time to deterioration in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire

Time to deterioration in disease-related physical symptoms (DRS-P) is defined as time (in days) from randomization to the earliest occurrence of 1) first reduction of DRS-P score from baseline ≥ 3 points, or 2) radiological progression or biochemical progression for Waldenström macroglobulinemia patients without lesions evaluable by imaging, or 3) death from any cause.

The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.



[Time Frame: Up to 52 months ]
Phase III_Time to deterioration in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire

Time to deterioration in disease-related physical symptoms (DRS-P) is defined as time (in days) from randomization to the earliest occurrence of 1) first reduction of DRS-P score from baseline ≥ 3 points, or 2) radiological progression or biochemical progression for Waldenström macroglobulinemia patients without lesions evaluable by imaging, or 3) death from any cause.

The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.



[Time Frame: Up to 52 months ]
13. Phase III_Number of participants with treatment-emergent adverse events
Up to 52 months
Phase III_Number of participants with treatment-emergent adverse events
Up to 52 months
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to:
    • Follicular lymphoma G1-2-3a
    • Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study entry
    • Lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM)
    • Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
  • Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab-based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response [PR] or complete response [CR]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor.
  • Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
  • Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test.
  • Male or female patients ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Life expectancy of at least 3 months
  • Availability of fresh tumor tissue and/or archival tumor tissue at Screening
  • Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
  • Left ventricular ejection fraction ≥ 50%

Exclusion Criteria

  • Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
  • Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab administration, including rituximab maintenance).
  • HbA1c > 8.5% at screening
  • History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
  • Known lymphomatous involvement of the central nervous system
  • Known history of human immunodeficiency virus (HIV) infection
  • Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
  • Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care.
  • Uncontrolled hypertension despite optimal medical management (per investigator´s assessment)
  • Congestive heart failure > New York Heart Association (NYHA) class 2

Inclusion Criteria:

  • Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to:
    • Follicular lymphoma G1-2-3a
    • Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study entry
    • Lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM)
    • Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
  • Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab-based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response [PR] or complete response [CR]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor.
  • Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
  • Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test.
  • Male or female patients ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Life expectancy of at least 3 months
  • Availability of fresh tumor tissue and/or archival tumor tissue at Screening
  • Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
  • Left ventricular ejection fraction ≥ 50%

Exclusion Criteria

  • Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
  • Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab administration, including rituximab maintenance).
  • HbA1c > 8.5% at screening
  • History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
  • Known lymphomatous involvement of the central nervous system
  • Known history of human immunodeficiency virus (HIV) infection
  • Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
  • Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care.
  • Uncontrolled hypertension despite optimal medical management (per investigator´s assessment)
  • Congestive heart failure > New York Heart Association (NYHA) class 2
Contacts/Locations
Central Contact: Bayer Clinical Trials Contact
Telephone: (+)1-888-84 22937
Email: clinical-trials-contact@bayer.com
Bayer Clinical Trials Contact
Telephone: (+)1-888-84 22937
Email: clinical-trials-contact@bayer.com
Study Officials: Bayer Study Director
Study Director
Bayer
Bayer Study Director
Study Director
Bayer
Locations: United States, AlaskaUnited States, Alaska
Alaska Cancer Treatment Center
[Recruiting]
Anchorage, Alaska, United States, 99503
Alaska Cancer Treatment Center
[Recruiting]
Anchorage, Alaska, United States, 99503
United States, ArizonaUnited States, Arizona
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
[Recruiting]
Chandler, Arizona, United States, 85224
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
[Recruiting]
Chandler, Arizona, United States, 85224
United States, CaliforniaUnited States, California
Compassionate Cancer Care Medical Group, Inc.
[Recruiting]
Fountain Valley, California, United States, 92708
Compassionate Cancer Care Medical Group, Inc.
[Recruiting]
Fountain Valley, California, United States, 92708
Univ.of California-San Diego Moores Cancer Center
[Recruiting]
La Jolla, California, United States, 92093-0698
Univ.of California-San Diego Moores Cancer Center
[Recruiting]
La Jolla, California, United States, 92093-0698
Pacific Shores Medical Group
[Recruiting]
Long Beach, California, United States, 90813
Pacific Shores Medical Group
[Recruiting]
Long Beach, California, United States, 90813
Brian J. LeBerthon, MD
[Recruiting]
West Covina, California, United States, 91790
Brian J. LeBerthon, MD
[Recruiting]
West Covina, California, United States, 91790
United States, ColoradoUnited States, Colorado
SCL Health Research at St Joseph's Hospital Denver CO
[Recruiting]
Denver, Colorado, United States, 80218
SCL Health Research at St Joseph's Hospital Denver CO
[Recruiting]
Denver, Colorado, United States, 80218
Comprehensive Cancer Care & Research Institute of Colorado
[Recruiting]
Englewood, Colorado, United States, 80113
Comprehensive Cancer Care & Research Institute of Colorado
[Recruiting]
Englewood, Colorado, United States, 80113
United States, ConnecticutUnited States, Connecticut
Hartford Hospital
[Withdrawn]
Hartford, Connecticut, United States, 06102-5037
Hartford Hospital
[Withdrawn]
Hartford, Connecticut, United States, 06102-5037
United States, FloridaUnited States, Florida
Mid Florida Cancer Centers
[Recruiting]
Orange City, Florida, United States, 32763
Mid Florida Cancer Centers
[Recruiting]
Orange City, Florida, United States, 32763
United States, GeorgiaUnited States, Georgia
John B. Amos Cancer Center
[Not yet recruiting]
Columbus, Georgia, United States, 31904
John B. Amos Cancer Center
[Recruiting]
Columbus, Georgia, United States, 31904
Lewis Hall Singletary Oncology Center
[Recruiting]
Thomasville, Georgia, United States, 31792
Lewis Hall Singletary Oncology Center
[Recruiting]
Thomasville, Georgia, United States, 31792
United States, HawaiiUnited States, Hawaii
The Queen's Medical Center
[Withdrawn]
Honolulu, Hawaii, United States, 96813-2413
The Queen's Medical Center
[Withdrawn]
Honolulu, Hawaii, United States, 96813-2413
United States, IdahoUnited States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
[Withdrawn]
Boise, Idaho, United States, 83712
St. Luke's Mountain States Tumor Institute - Boise
[Withdrawn]
Boise, Idaho, United States, 83712
United States, IllinoisUnited States, Illinois
Alexian Brothers Medical Center
[Withdrawn]
Elk Grove Village, Illinois, United States, 60007
Alexian Brothers Medical Center
[Withdrawn]
Elk Grove Village, Illinois, United States, 60007
Loyola University Medical Center
[Withdrawn]
Maywood, Illinois, United States, 60153
Loyola University Medical Center
[Withdrawn]
Maywood, Illinois, United States, 60153
United States, MarylandUnited States, Maryland
Greenebaum Comprehensive Cancer Center
[Recruiting]
Baltimore, Maryland, United States, 21201
Greenebaum Comprehensive Cancer Center
[Recruiting]
Baltimore, Maryland, United States, 21201
United States, MichiganUnited States, Michigan
Henry Ford Health System
[Recruiting]
Detroit, Michigan, United States, 48202
Henry Ford Health System
[Recruiting]
Detroit, Michigan, United States, 48202
Detroit Clinical Research Center
[Withdrawn]
Farmington Hills, Michigan, United States, 48334
Detroit Clinical Research Center
[Withdrawn]
Farmington Hills, Michigan, United States, 48334
United States, MinnesotaUnited States, Minnesota
Mayo Clinic - Rochester
[Recruiting]
Rochester, Minnesota, United States, 55905
Mayo Clinic - Rochester
[Recruiting]
Rochester, Minnesota, United States, 55905
United States, MississippiUnited States, Mississippi
University of Mississippi Medical Center
[Recruiting]
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center
[Recruiting]
Jackson, Mississippi, United States, 39216
United States, New JerseyUnited States, New Jersey
Memorial Sloan Kettering Cancer Center- Basking Ridge
[Recruiting]
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Cancer Center- Basking Ridge
[Recruiting]
Basking Ridge, New Jersey, United States, 07920
Hackensack University Medical Center
[Withdrawn]
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
[Withdrawn]
Hackensack, New Jersey, United States, 07601
Memorial Sloan Kettering Cancer Center- Monmouth
[Recruiting]
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Cancer Center- Monmouth
[Recruiting]
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Cancer Center- Bergen
[Recruiting]
Montvale, New Jersey, United States, 07645
Memorial Sloan Kettering Cancer Center- Bergen
[Recruiting]
Montvale, New Jersey, United States, 07645
Morristown Memorial Hospital
[Recruiting]
Morristown, New Jersey, United States, 07962-1956
Morristown Memorial Hospital
[Recruiting]
Morristown, New Jersey, United States, 07962-1956
Valley Hospital Bolger Medical Arts Building
[Recruiting]
Westwood, New Jersey, United States, 07675
Valley Hospital Bolger Medical Arts Building
[Recruiting]
Westwood, New Jersey, United States, 07675
United States, New YorkUnited States, New York
Memorial Sloan Kettering Cancer Center- Commack
[Recruiting]
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center- Commack
[Recruiting]
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center- Westchester
[Recruiting]
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center- Westchester
[Recruiting]
Harrison, New York, United States, 10604
Winthrop-University Hospital
[Withdrawn]
Mineola, New York, United States, 11501-3987
Winthrop-University Hospital
[Withdrawn]
Mineola, New York, United States, 11501-3987
NYU Langone Medical Center
[Withdrawn]
New York, New York, United States, 10016-4576
NYU Langone Medical Center
[Withdrawn]
New York, New York, United States, 10016-4576
Memorial Sloan-Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Hematology Oncology Center at Nyack Hospital
[Recruiting]
Nyack, New York, United States, 19060
Hematology Oncology Center at Nyack Hospital
[Recruiting]
Nyack, New York, United States, 19060
New York Cancer and Blood Specialists
[Recruiting]
Port Jefferson Station, New York, United States, 11776
New York Cancer and Blood Specialists
[Recruiting]
Port Jefferson Station, New York, United States, 11776
Memorial Sloan Kettering- Nassau
[Recruiting]
Uniondale, New York, United States, 11553
Memorial Sloan Kettering- Nassau
[Recruiting]
Uniondale, New York, United States, 11553
United States, North CarolinaUnited States, North Carolina
Mission Hospital
[Withdrawn]
Asheville, North Carolina, United States, 28801
Mission Hospital
[Withdrawn]
Asheville, North Carolina, United States, 28801
East Carolina University
[Recruiting]
Greenville, North Carolina, United States, 27834
East Carolina University
[Recruiting]
Greenville, North Carolina, United States, 27834
United States, OhioUnited States, Ohio
Gabrail Cancer Center
[Recruiting]
Canton, Ohio, United States, 44718
Gabrail Cancer Center
[Recruiting]
Canton, Ohio, United States, 44718
Mid Ohio Oncology/Hematology Inc.
[Withdrawn]
Columbus, Ohio, United States, 43219
Mid Ohio Oncology/Hematology Inc.
[Withdrawn]
Columbus, Ohio, United States, 43219
United States, OklahomaUnited States, Oklahoma
Southwest Oklahoma Cancer Research
[Recruiting]
Lawton, Oklahoma, United States, 73505
Southwest Oklahoma Cancer Research
[Recruiting]
Lawton, Oklahoma, United States, 73505
United States, South DakotaUnited States, South Dakota
Prairie Lakes Cancer Center
[Recruiting]
Watertown, South Dakota, United States, 57201
Prairie Lakes Cancer Center
[Recruiting]
Watertown, South Dakota, United States, 57201
United States, TexasUnited States, Texas
Oncology Consultants
[Recruiting]
Houston, Texas, United States, 77030
Oncology Consultants
[Recruiting]
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
[Withdrawn]
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
[Withdrawn]
Houston, Texas, United States, 77030
DBA-Envision Cancer Care, LLC
[Withdrawn]
Laredo, Texas, United States, 78041
DBA-Envision Cancer Care, LLC
[Withdrawn]
Laredo, Texas, United States, 78041
Joe Arrington Cancer Research & Treatment Center
[Recruiting]
Lubbock, Texas, United States, 79410
Joe Arrington Cancer Research & Treatment Center
[Recruiting]
Lubbock, Texas, United States, 79410
University Health System
[Withdrawn]
Lubbock, Texas, United States, 79415
University Health System
[Withdrawn]
Lubbock, Texas, United States, 79415
Texas Oncology- McAllen
[Recruiting]
McAllen, Texas, United States, 78603
Texas Oncology- McAllen
[Recruiting]
McAllen, Texas, United States, 78603
United States, WashingtonUnited States, Washington
Vista Oncology Inc PS
[Recruiting]
Olympia, Washington, United States, 98502
Vista Oncology Inc PS
[Recruiting]
Olympia, Washington, United States, 98502
Medical Oncology Associates, PS
[Recruiting]
Spokane, Washington, United States, 99208-1129
Medical Oncology Associates, PS
[Recruiting]
Spokane, Washington, United States, 99208-1129
Australia, New South WalesAustralia, New South Wales
Kinghorn Cancer Centre
[Withdrawn]
Darlinghurst, New South Wales, Australia, 2010
Kinghorn Cancer Centre
[Withdrawn]
Darlinghurst, New South Wales, Australia, 2010
Calvary Mater Hospital Newcastle
[Recruiting]
Waratah, New South Wales, Australia, 2298
Calvary Mater Hospital Newcastle
[Recruiting]
Waratah, New South Wales, Australia, 2298
Australia, QueenslandAustralia, Queensland
Pindara Private Hospital
[Recruiting]
Benowa, Queensland, Australia, 4217
Pindara Private Hospital
[Recruiting]
Benowa, Queensland, Australia, 4217
Royal Brisbane & Women's Hospital
[Withdrawn]
Brisbane, Queensland, Australia, 4029
Royal Brisbane & Women's Hospital
[Withdrawn]
Brisbane, Queensland, Australia, 4029
Australia, South AustraliaAustralia, South Australia
Flinders Medical Centre
[Recruiting]
Adelaide, South Australia, Australia, 5042
Flinders Medical Centre
[Recruiting]
Adelaide, South Australia, Australia, 5042
Ashford Cancer Centre Pty Ltd
[Recruiting]
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Pty Ltd
[Recruiting]
Kurralta Park, South Australia, Australia, 5037
Australia, VictoriaAustralia, Victoria
Frankston Hospital
[Withdrawn]
Frankston, Victoria, Australia, 3199
Frankston Hospital
[Withdrawn]
Frankston, Victoria, Australia, 3199
The Alfred Hospital
[Recruiting]
Prahran, Victoria, Australia, 3181
The Alfred Hospital
[Recruiting]
Prahran, Victoria, Australia, 3181
Australia, Western AustraliaAustralia, Western Australia
Fiona Stanley Hospital
[Recruiting]
Murdoch, Western Australia, Australia, 6150
Fiona Stanley Hospital
[Recruiting]
Murdoch, Western Australia, Australia, 6150
AustraliaAustralia
Eastern Health Integrated Renal Service
[Recruiting]
Box Hill, Australia, 3128
Eastern Health Integrated Renal Service
[Recruiting]
Box Hill, Australia, 3128
AustriaAustria
Klinikum Wels-Grieskirchen GmbH
[Withdrawn]
Wels, Austria, 4600
Klinikum Wels-Grieskirchen GmbH
[Withdrawn]
Wels, Austria, 4600
Belgium, AntwerpenBelgium, Antwerpen
GZA Ziekenhuizen
[Recruiting]
Wilrijk, Antwerpen, Belgium, 2610
GZA Ziekenhuizen
[Recruiting]
Wilrijk, Antwerpen, Belgium, 2610
Belgium, West-VlaanderenBelgium, West-Vlaanderen
AZ Groeninge Campus Kennedylaan
[Recruiting]
Kortrijk, West-Vlaanderen, Belgium, 8500
AZ Groeninge Campus Kennedylaan
[Recruiting]
Kortrijk, West-Vlaanderen, Belgium, 8500
BelgiumBelgium
Institut Jules Bordet/Jules Bordet Instituut
[Recruiting]
Bruxelles - Brussel, Belgium, 1000
Institut Jules Bordet/Jules Bordet Instituut
[Recruiting]
Bruxelles - Brussel, Belgium, 1000
Grand Hôpital de Charleroi
[Recruiting]
Charleroi, Belgium, 6000
Grand Hôpital de Charleroi
[Recruiting]
Charleroi, Belgium, 6000
UZ Gent
[Recruiting]
Gent, Belgium, 9000
UZ Gent
[Recruiting]
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
[Recruiting]
Leuven, Belgium, 3000
UZ Leuven Gasthuisberg
[Recruiting]
Leuven, Belgium, 3000
CHU de Liège
[Recruiting]
Liege, Belgium, 4000
CHU de Liège
[Recruiting]
Liege, Belgium, 4000
Brazil, ParanaBrazil, Parana
Centro Integrado de Oncologia de Curitiba
[Recruiting]
Curitiba, Parana, Brazil, 80810-050
Centro Integrado de Oncologia de Curitiba
[Recruiting]
Curitiba, Parana, Brazil, 80810-050
Brazil, Rio Grande Do SulBrazil, Rio Grande Do Sul
Hosp Bruno Born Sociedade Beneficência e Caridade de Lajeado
[Not yet recruiting]
Lajeado, Rio Grande Do Sul, Brazil
Hosp Bruno Born Sociedade Beneficência e Caridade de Lajeado
[Not yet recruiting]
Lajeado, Rio Grande Do Sul, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
Irmandade Santa Casa de Misericordia de Porto Alegre
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
Hospital de Clínicas de Porto Alegre
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil
Brazil, Santa CatarinaBrazil, Santa Catarina
Centro de Pesquisas Oncológicas
[Recruiting]
Florianópolis, Santa Catarina, Brazil, 88034-000
Centro de Pesquisas Oncológicas
[Recruiting]
Florianópolis, Santa Catarina, Brazil, 88034-000
Brazil, Sao PauloBrazil, Sao Paulo
Faculdade de Ciencias Medicas-Universidade Estadual Campinas
[Recruiting]
Campinas, Sao Paulo, Brazil, 130839 970
Faculdade de Ciencias Medicas-Universidade Estadual Campinas
[Recruiting]
Campinas, Sao Paulo, Brazil, 130839 970
Faculdade de Medicina do ABC
[Recruiting]
Santo Andre, Sao Paulo, Brazil
Faculdade de Medicina do ABC
[Recruiting]
Santo Andre, Sao Paulo, Brazil
IEP São Lucas
[Recruiting]
São Paulo, Sao Paulo, Brazil, 01236-030
IEP São Lucas
[Recruiting]
São Paulo, Sao Paulo, Brazil, 01236-030
Hospital das Clínicas da Faculdade de Medicina da USP
[Recruiting]
São Paulo, Sao Paulo, Brazil, 05403-000.
Hospital das Clínicas da Faculdade de Medicina da USP
[Recruiting]
São Paulo, Sao Paulo, Brazil, 05403-000.
Casa de Saúde Santa Marcelina
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 08.270-070
Casa de Saúde Santa Marcelina
[Not yet recruiting]
São Paulo, Sao Paulo, Brazil, 08.270-070
BrazilBrazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva
[Recruiting]
Rio de Janeiro, Brazil, 20230 130
Instituto Nacional do Cancer Jose Alencar Gomes da Silva
[Recruiting]
Rio de Janeiro, Brazil, 20230 130
Hospital Samaritano de São Paulo LTDA
[Withdrawn]
Sao Paulo, Brazil, 01236-000
Hospital Samaritano de São Paulo LTDA
[Withdrawn]
Sao Paulo, Brazil, 01236-000
Hospital Israelita Albert Einstein
[Recruiting]
Sao Paulo, Brazil, 05651-901
Hospital Israelita Albert Einstein
[Recruiting]
Sao Paulo, Brazil, 05651-901
BulgariaBulgaria
UMHAT Sveti Georgi
[Recruiting]
Plovdiv, Bulgaria, 4002
UMHAT Sveti Georgi
[Recruiting]
Plovdiv, Bulgaria, 4002
University Multiprofile Hosp. for Active Treat. Sveti Ivan
[Recruiting]
Sofia, Bulgaria, 1431
University Multiprofile Hosp. for Active Treat. Sveti Ivan
[Recruiting]
Sofia, Bulgaria, 1431
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
[Recruiting]
Sofia, Bulgaria, 1756
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
[Recruiting]
Sofia, Bulgaria, 1756
Multiprofile Hospital for Active Treatment Hristo Botev AD
[Recruiting]
Vratsa, Bulgaria, 3000
Multiprofile Hospital for Active Treatment Hristo Botev AD
[Recruiting]
Vratsa, Bulgaria, 3000
Canada, QuebecCanada, Quebec
Hopital Maisonneuve-Rosemont
[Recruiting]
Montreal, Quebec, Canada, H1T 2M4
Hopital Maisonneuve-Rosemont
[Recruiting]
Montreal, Quebec, Canada, H1T 2M4
Hopital du Sacre-Coeur de Montreal
[Recruiting]
Montreal, Quebec, Canada, H4J 1C5
Hopital du Sacre-Coeur de Montreal
[Recruiting]
Montreal, Quebec, Canada, H4J 1C5
Hopital de L'Enfant Jesus
[Recruiting]
Quebec City, Quebec, Canada, G1J 1Z4
Hopital de L'Enfant Jesus
[Recruiting]
Quebec City, Quebec, Canada, G1J 1Z4
Centre Universitaire de Sante de l'Estrie
[Recruiting]
Sherbrooke, Quebec, Canada, J1H 5N4
Centre Universitaire de Sante de l'Estrie
[Recruiting]
Sherbrooke, Quebec, Canada, J1H 5N4
Chile, AraucaníaChile, Araucanía
Sociedad de Investigaciones Medicas Ltda
[Recruiting]
Temuco, Araucanía, Chile, 4810469
Sociedad de Investigaciones Medicas Ltda
[Recruiting]
Temuco, Araucanía, Chile, 4810469
Chile, ValparaísoChile, Valparaíso
Centro de Investigaciones Clínicas Viña del Mar Ltda.
[Suspended]
Viña del Mar, Valparaíso, Chile, 2540364
Centro de Investigaciones Clínicas Viña del Mar Ltda.
[Suspended]
Viña del Mar, Valparaíso, Chile, 2540364
ChileChile
Fundación Arturo López Perez
[Withdrawn]
Santiago, Chile, 7500921
Fundación Arturo López Perez
[Withdrawn]
Santiago, Chile, 7500921
Clínica Santa María
[Withdrawn]
Santiago, Chile, 7520378
Clínica Santa María
[Withdrawn]
Santiago, Chile, 7520378
Instituto Nacional del Cáncer
[Recruiting]
Santiago, Chile, 838-0455
Instituto Nacional del Cáncer
[Recruiting]
Santiago, Chile, 838-0455
China, FujianChina, Fujian
FuJian Medical University Union Hospital
[Recruiting]
Fuzhou, Fujian, China, 350001
FuJian Medical University Union Hospital
[Recruiting]
Fuzhou, Fujian, China, 350001
China, GuangdongChina, Guangdong
Sun Yat-sen University Cancer Center
[Recruiting]
Guangzhou, Guangdong, China, 510060
Sun Yat-sen University Cancer Center
[Recruiting]
Guangzhou, Guangdong, China, 510060
Guangdong General Hospital
[Recruiting]
Guangzhou, Guangdong, China, 510100
Guangdong General Hospital
[Recruiting]
Guangzhou, Guangdong, China, 510100
China, HenanChina, Henan
Henan Cancer Hospital
[Recruiting]
Zhengzhou, Henan, China, 450008
Henan Cancer Hospital
[Recruiting]
Zhengzhou, Henan, China, 450008
China, JiangsuChina, Jiangsu
Jiangsu Cancer Hospital
[Recruiting]
Nanjing, Jiangsu, China, 210009
Jiangsu Cancer Hospital
[Recruiting]
Nanjing, Jiangsu, China, 210009
1st Affiliated hospital of Soochow University
[Recruiting]
Suzhou, Jiangsu, China, 215006
1st Affiliated hospital of Soochow University
[Recruiting]
Suzhou, Jiangsu, China, 215006
China, ShaanxiChina, Shaanxi
Tangdu Hospital, the 4th Military Medical University of PLA
[Recruiting]
Xi'an, Shaanxi, China, 710038
Tangdu Hospital, the 4th Military Medical University of PLA
[Recruiting]
Xi'an, Shaanxi, China, 710038
China, ShandongChina, Shandong
The Affiliated Hospital of Qingdao University
[Recruiting]
Qingdao, Shandong, China, 266500
The Affiliated Hospital of Qingdao University
[Recruiting]
Qingdao, Shandong, China, 266500
China, SichuanChina, Sichuan
West China Hospital, Sichuan University
[Recruiting]
Chengdu, Sichuan, China, 610041
West China Hospital, Sichuan University
[Recruiting]
Chengdu, Sichuan, China, 610041
China, ZhejiangChina, Zhejiang
The 1st Affiliated Hospital of Zhejiang University
[Recruiting]
Hangzhou, Zhejiang, China, 310003
The 1st Affiliated Hospital of Zhejiang University
[Recruiting]
Hangzhou, Zhejiang, China, 310003
Zhejiang Cancer Hospital
[Recruiting]
Hangzhou, Zhejiang, China, 310022
Zhejiang Cancer Hospital
[Recruiting]
Hangzhou, Zhejiang, China, 310022
ChinaChina
Cancer Hospital, Chinese Academy of Medical Sciences
[Not yet recruiting]
Beijing, China, 100021
Cancer Hospital, Chinese Academy of Medical Sciences
[Not yet recruiting]
Beijing, China, 100021
Beijing Friendship Hospital, Capital Medical University
[Recruiting]
Beijing, China, 100050
Beijing Friendship Hospital, Capital Medical University
[Recruiting]
Beijing, China, 100050
Fifth Medical Center, General Hospital of the Chinese People
[Recruiting]
Beijing, China, 100071
Fifth Medical Center, General Hospital of the Chinese People
[Recruiting]
Beijing, China, 100071
Jilin Cancer Hospital
[Recruiting]
Changchun, China, 130012
Jilin Cancer Hospital
[Recruiting]
Changchun, China, 130012
Fudan University Shanghai Cancer Center
[Recruiting]
Shanghai, China, 200030
Fudan University Shanghai Cancer Center
[Recruiting]
Shanghai, China, 200030
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
[Recruiting]
Shanghai, China, 200092
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
[Recruiting]
Shanghai, China, 200092
Shanghai East Hospital Affiated to Tongji University
[Recruiting]
Shanghai, China, 200123
Shanghai East Hospital Affiated to Tongji University
[Recruiting]
Shanghai, China, 200123
Tumor Hospital of Hebei Province
[Recruiting]
Shijiazhuang, China, 050011
Tumor Hospital of Hebei Province
[Recruiting]
Shijiazhuang, China, 050011
Tianjin Medical University Cancer Institiute & Hospital
[Recruiting]
Tianjin, China, 300060
Tianjin Medical University Cancer Institiute & Hospital
[Recruiting]
Tianjin, China, 300060
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
[Recruiting]
Tianjin, China, 300121
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
[Recruiting]
Tianjin, China, 300121
CzechiaCzechia
Fakultni Nemocnice Hradec Kralove
[Recruiting]
Hradec Kralove, Czechia, 50005
Fakultni Nemocnice Hradec Kralove
[Recruiting]
Hradec Kralove, Czechia, 50005
Fakultni nemocnice Kralovske Vinohrady
[Recruiting]
Praha 10, Czechia, 100 34
Fakultni nemocnice Kralovske Vinohrady
[Recruiting]
Praha 10, Czechia, 100 34
DenmarkDenmark
H:S Rigshospitalet
[Recruiting]
Copenhagen, Denmark, 2100
H:S Rigshospitalet
[Recruiting]
Copenhagen, Denmark, 2100
Odense Universitetshospital
[Recruiting]
Odense C, Denmark, DK-5000
Odense Universitetshospital
[Recruiting]
Odense C, Denmark, DK-5000
FinlandFinland
HUS, Meilahden sairaala
[Recruiting]
Helsinki, Finland, 00290
HUS, Meilahden sairaala
[Recruiting]
Helsinki, Finland, 00290
Keski-Suomen keskussairaala
[Recruiting]
Jyväskylä, Finland, 40620
Keski-Suomen keskussairaala
[Recruiting]
Jyväskylä, Finland, 40620
Oulun yliopistollinen sairaala
[Recruiting]
Oulu, Finland, 90020
Oulun yliopistollinen sairaala
[Recruiting]
Oulu, Finland, 90020
Tampereen yliopistollinen sairaala, keskussairaala
[Recruiting]
Tampere, Finland, 33521
Tampereen yliopistollinen sairaala, keskussairaala
[Recruiting]
Tampere, Finland, 33521
Turun yliopistollinen keskussairaala, kantasairaala
[Recruiting]
Turku, Finland, 20520
Turun yliopistollinen keskussairaala, kantasairaala
[Recruiting]
Turku, Finland, 20520
FranceFrance
Centre Hospitalier Universitaire - Angers
[Recruiting]
Angers, France, 49100
Centre Hospitalier Universitaire - Angers
[Recruiting]
Angers, France, 49100
Centre Hospitalier de la Durance - Avignon
[Recruiting]
Avignon, France, 84000
Centre Hospitalier de la Durance - Avignon
[Recruiting]
Avignon, France, 84000
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
[Recruiting]
Bayonne, France, 64100
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
[Recruiting]
Bayonne, France, 64100
CHU de Caen, Hôpital Côte de la Côte de Nacre
[Recruiting]
Caen Cedex, France, 14033
CHU de Caen, Hôpital Côte de la Côte de Nacre
[Recruiting]
Caen Cedex, France, 14033
Hôpital Henri Mondor
[Recruiting]
Creteil, France, 94010
Hôpital Henri Mondor
[Recruiting]
Creteil, France, 94010
Centre Hospitalier Universite de Grenoble
[Recruiting]
Grenoble, France, 38043
Centre Hospitalier Universite de Grenoble
[Recruiting]
Grenoble, France, 38043
Clinique Victor Hugo - Le Mans
[Recruiting]
Le Mans Cedex 2, France, 72015
Clinique Victor Hugo - Le Mans
[Recruiting]
Le Mans Cedex 2, France, 72015
Hôpital Dupuytren
[Recruiting]
Limoges Cedex, France, 87042
Hôpital Dupuytren
[Recruiting]
Limoges Cedex, France, 87042
Centre Léon Bérard
[Withdrawn]
Lyon Cedex, France, 69008
Centre Léon Bérard
[Withdrawn]
Lyon Cedex, France, 69008
Hôpital Saint-Eloi
[Recruiting]
Montpellier Cedex, France, 34295
Hôpital Saint-Eloi
[Recruiting]
Montpellier Cedex, France, 34295
Hôpital Hôtel Dieu
[Recruiting]
Nantes Cedex, France, 44093
Hôpital Hôtel Dieu
[Recruiting]
Nantes Cedex, France, 44093
Hôpital Saint Louis
[Recruiting]
Paris, France, 75010
Hôpital Saint Louis
[Recruiting]
Paris, France, 75010
Hopital Saint Antoine - Paris
[Not yet recruiting]
Paris, France, 75571
Hopital Saint Antoine - Paris
[Withdrawn]
Paris, France, 75571
Centre François Magendie - Pessac
[Recruiting]
Pessac, France, 33600
Centre François Magendie - Pessac
[Recruiting]
Pessac, France, 33600
Centre Hospitalier Lyon Sud
[Withdrawn]
Pierre Benite, France, 69310
Centre Hospitalier Lyon Sud
[Withdrawn]
Pierre Benite, France, 69310
Hôpital de la Milétrie
[Recruiting]
Poitiers, France, 86021
Hôpital de la Milétrie
[Recruiting]
Poitiers, France, 86021
Centre Henri Becquerel
[Withdrawn]
Rouen, France, 76038
Centre Henri Becquerel
[Withdrawn]
Rouen, France, 76038
Centre René Gauducheau - Nantes
[Withdrawn]
Saint Herblain, France, 44805
Centre René Gauducheau - Nantes
[Withdrawn]
Saint Herblain, France, 44805
Clinique Saint Anne
[Recruiting]
Strasbourg, France, 67000
Clinique Saint Anne
[Recruiting]
Strasbourg, France, 67000
Germany, Baden-WürttembergGermany, Baden-Württemberg
Stauferklinikum Schwäbisch-Gmünd
[Recruiting]
Mutlangen, Baden-Württemberg, Germany, 73557
Stauferklinikum Schwäbisch-Gmünd
[Recruiting]
Mutlangen, Baden-Württemberg, Germany, 73557
Germany, BayernGermany, Bayern
Gemeinschaftspraxis Dr.Heinrich/ Prof.Bangerter
[Recruiting]
Augsburg, Bayern, Germany, 86150
Gemeinschaftspraxis Dr.Heinrich/ Prof.Bangerter
[Recruiting]
Augsburg, Bayern, Germany, 86150
Klinikum der Universität München Grosshadern
[Recruiting]
München, Bayern, Germany, 81377
Klinikum der Universität München Grosshadern
[Recruiting]
München, Bayern, Germany, 81377
MVZ Praxis Pihusch GbR
[Recruiting]
Rosenheim, Bayern, Germany, 83022
MVZ Praxis Pihusch GbR
[Recruiting]
Rosenheim, Bayern, Germany, 83022
Germany, Mecklenburg-VorpommernGermany, Mecklenburg-Vorpommern
Universität Rostock - Medizinische Fakultät
[Recruiting]
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Universität Rostock - Medizinische Fakultät
[Recruiting]
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Germany, NiedersachsenGermany, Niedersachsen
Medizinische Hochschule Hannover (MHH)
[Recruiting]
Hannover, Niedersachsen, Germany, 30625
Medizinische Hochschule Hannover (MHH)
[Recruiting]
Hannover, Niedersachsen, Germany, 30625
Onkolog. Gemeinschaftspraxis Dres. D.Reichert & J.Janssen
[Recruiting]
Westerstede, Niedersachsen, Germany, 26655
Onkolog. Gemeinschaftspraxis Dres. D.Reichert & J.Janssen
[Recruiting]
Westerstede, Niedersachsen, Germany, 26655
Germany, Nordrhein-WestfalenGermany, Nordrhein-Westfalen
Marienhospital Herne Universitätsklinik
[Recruiting]
Herne, Nordrhein-Westfalen, Germany, 44625
Marienhospital Herne Universitätsklinik
[Recruiting]
Herne, Nordrhein-Westfalen, Germany, 44625
Universitätsklinikum Münster (UKM)
[Recruiting]
Münster, Nordrhein-Westfalen, Germany, 48149
Universitätsklinikum Münster (UKM)
[Recruiting]
Münster, Nordrhein-Westfalen, Germany, 48149
Oncologianova GmbH
[Recruiting]
Recklinghausen, Nordrhein-Westfalen, Germany, 45659
Oncologianova GmbH
[Recruiting]
Recklinghausen, Nordrhein-Westfalen, Germany, 45659
Germany, Sachsen-AnhaltGermany, Sachsen-Anhalt
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
[Recruiting]
Halle, Sachsen-Anhalt, Germany, 06120
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
[Recruiting]
Halle, Sachsen-Anhalt, Germany, 06120
GermanyGermany
Ruppiner Kliniken GmbH
[Withdrawn]
Neuruppin, Germany, 16816
Ruppiner Kliniken GmbH
[Withdrawn]
Neuruppin, Germany, 16816
GreeceGreece
Evangelismos General Hospital of Athens
[Recruiting]
Athens, Greece, 106 76
Evangelismos General Hospital of Athens
[Recruiting]
Athens, Greece, 106 76
Laiko General Hospital of Athens (Sevastoupoleos)
[Recruiting]
Athens, Greece, 115 26
Laiko General Hospital of Athens (Sevastoupoleos)
[Recruiting]
Athens, Greece, 115 26
University General Hospital of Athens "ATTIKON"
[Recruiting]
Chaidari, Greece, 12462
University General Hospital of Athens "ATTIKON"
[Recruiting]
Chaidari, Greece, 12462
University General Hospital of Larissa
[Recruiting]
Larissa, Greece, 41100
University General Hospital of Larissa
[Recruiting]
Larissa, Greece, 41100
University General Hospital of Patras
[Recruiting]
Patras, Greece, 26500
University General Hospital of Patras
[Recruiting]
Patras, Greece, 26500
G. Papanikolaou General Hospital of Thessaloniki
[Withdrawn]
Thessaloniki, Greece, 57010
G. Papanikolaou General Hospital of Thessaloniki
[Withdrawn]
Thessaloniki, Greece, 57010
Hong KongHong Kong
Queen Mary Hospital
[Recruiting]
Hong Kong, Hong Kong
Queen Mary Hospital
[Recruiting]
Hong Kong, Hong Kong
Tuen Mun Hospital
[Recruiting]
Hongkong, Hong Kong
Tuen Mun Hospital
[Recruiting]
Hongkong, Hong Kong
Queen Elizabeth Hospital
[Recruiting]
Kowloon, Hong Kong
Queen Elizabeth Hospital
[Recruiting]
Kowloon, Hong Kong
Prince of Wales Hospital
[Recruiting]
Shatin, Hong Kong
Prince of Wales Hospital
[Recruiting]
Shatin, Hong Kong
HungaryHungary
Semmelweis University
[Recruiting]
Budapest, Hungary, 1083
Semmelweis University
[Recruiting]
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet
[Recruiting]
Budapest, Hungary, 1122
Orszagos Onkologiai Intezet
[Recruiting]
Budapest, Hungary, 1122
Semmelweis University
[Recruiting]
Budapest, Hungary, 1125
Semmelweis University
[Recruiting]
Budapest, Hungary, 1125
Somogy Megyei Kaposi Mor Oktato Korhaz
[Recruiting]
Kaposvar, Hungary, 7400
Somogy Megyei Kaposi Mor Oktato Korhaz
[Recruiting]
Kaposvar, Hungary, 7400
Bacs-Kiskun Country Hospital
[Withdrawn]
Kecskemét, Hungary, 6000
Bacs-Kiskun Country Hospital
[Withdrawn]
Kecskemét, Hungary, 6000
SzSzBMK es EOK Josa Andras Oktatokorhaz
[Recruiting]
Nyiregyhaza, Hungary, 4400
SzSzBMK es EOK Josa Andras Oktatokorhaz
[Recruiting]
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Klinikai Kozpont
[Recruiting]
Pecs, Hungary, 7624
Pecsi Tudomanyegyetem Klinikai Kozpont
[Recruiting]
Pecs, Hungary, 7624
Szent Borbala Hospital
[Recruiting]
Tatabanya, Hungary, 2800
Szent Borbala Hospital
[Recruiting]
Tatabanya, Hungary, 2800
IrelandIreland
Cork University Hospital
[Recruiting]
Cork, Ireland
Cork University Hospital
[Recruiting]
Cork, Ireland
Misericordiae Hospital
[Recruiting]
Dublin, Ireland, 7
Misericordiae Hospital
[Recruiting]
Dublin, Ireland, 7
St James's Hospital
[Withdrawn]
Dublin, Ireland
St James's Hospital
[Withdrawn]
Dublin, Ireland
IsraelIsrael
Rambam Health Corporation
[Recruiting]
Haifa, Israel, 3109601
Rambam Health Corporation
[Recruiting]
Haifa, Israel, 3109601
Edith Wolfson Medical Center
[Withdrawn]
Holon, Israel, 5810001
Edith Wolfson Medical Center
[Withdrawn]
Holon, Israel, 5810001
Hadassah Hebrew University Hospital Ein Kerem
[Recruiting]
Jerusalem, Israel, 9112001
Hadassah Hebrew University Hospital Ein Kerem
[Recruiting]
Jerusalem, Israel, 9112001
Meir Medical Center
[Withdrawn]
Kfar Saba, Israel, 4428164
Meir Medical Center
[Withdrawn]
Kfar Saba, Israel, 4428164
Chaim Sheba Medical Center
[Recruiting]
Ramat Gan, Israel, 5262000
Chaim Sheba Medical Center
[Recruiting]
Ramat Gan, Israel, 5262000
Assaf Harofeh Medical Center
[Recruiting]
Zerifin, Israel, 6093000
The Shamir Medical Center (Assaf Harofeh)
[Recruiting]
Zerifin, Israel, 6093000
Italy, Emilia-RomagnaItaly, Emilia-Romagna
A.O.U. di Bologna Policlinico S.Orsola Malpighi
[Recruiting]
Bologna, Emilia-Romagna, Italy, 40138
A.O.U. di Bologna Policlinico S.Orsola Malpighi
[Recruiting]
Bologna, Emilia-Romagna, Italy, 40138
AUSL della Romagna
[Recruiting]
Ravenna, Emilia-Romagna, Italy, 48121
AUSL della Romagna
[Recruiting]
Ravenna, Emilia-Romagna, Italy, 48121
Italy, LiguriaItaly, Liguria
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
[Recruiting]
Genova, Liguria, Italy, 16132
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
[Recruiting]
Genova, Liguria, Italy, 16132
Italy, LombardiaItaly, Lombardia
IRCCS Istituto Clinico Humanitas (ICH)
[Recruiting]
Milano, Lombardia, Italy, 20089
IRCCS Istituto Clinico Humanitas (ICH)
[Recruiting]
Milano, Lombardia, Italy, 20089
IRCCS Istituto Europeo di Oncologia (IEO)
[Recruiting]
Milano, Lombardia, Italy, 20141
IRCCS Istituto Europeo di Oncologia (IEO)
[Recruiting]
Milano, Lombardia, Italy, 20141
IRCCS Fondazione Policlinico San Matteo
[Recruiting]
Pavia, Lombardia, Italy, 27100
IRCCS Fondazione Policlinico San Matteo
[Recruiting]
Pavia, Lombardia, Italy, 27100
Italy, MarcheItaly, Marche
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
[Recruiting]
Ancona, Marche, Italy, 60100
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
[Recruiting]
Ancona, Marche, Italy, 60100
Japan, AichiJapan, Aichi
National Hospital Organization Nagoya Medical Center
[Recruiting]
Nagoya, Aichi, Japan, 460-0001
National Hospital Organization Nagoya Medical Center
[Recruiting]
Nagoya, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital
[Recruiting]
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center Hospital
[Recruiting]
Nagoya, Aichi, Japan, 464-8681
Japanese Red Cross Nagoya Daini Hospital
[Recruiting]
Nagoya, Aichi, Japan, 466-8650
Japanese Red Cross Nagoya Daini Hospital
[Recruiting]
Nagoya, Aichi, Japan, 466-8650
Nagoya City University Hospital
[Recruiting]
Nagoya, Aichi, Japan, 467-8602
Nagoya City University Hospital
[Recruiting]
Nagoya, Aichi, Japan, 467-8602
Japan, FukuokaJapan, Fukuoka
JCHO Kyushu Hospital
[Recruiting]
Kitakyushu, Fukuoka, Japan, 806-8501
JCHO Kyushu Hospital
[Recruiting]
Kitakyushu, Fukuoka, Japan, 806-8501
Kurume University Hospital
[Withdrawn]
Kurume, Fukuoka, Japan, 830-0011
Kurume University Hospital
[Withdrawn]
Kurume, Fukuoka, Japan, 830-0011
Japan, GunmaJapan, Gunma
Gunma University Hospital
[Recruiting]
Maebashi, Gunma, Japan, 371-8511
Gunma University Hospital
[Recruiting]
Maebashi, Gunma, Japan, 371-8511
Japan, HyogoJapan, Hyogo
Hyogo Cancer Center
[Recruiting]
Akashi, Hyogo, Japan, 673-8558
Hyogo Cancer Center
[Recruiting]
Akashi, Hyogo, Japan, 673-8558
Kobe University Hospital
[Recruiting]
Kobe, Hyogo, Japan, 650-0017
Kobe University Hospital
[Recruiting]
Kobe, Hyogo, Japan, 650-0017
Japan, KanagawaJapan, Kanagawa
Kanagawa Cancer Center
[Recruiting]
Yokohama, Kanagawa, Japan, 241-8515
Kanagawa Cancer Center
[Recruiting]
Yokohama, Kanagawa, Japan, 241-8515
Japan, MiyagiJapan, Miyagi
Tohoku University Hospital
[Recruiting]
Sendai, Miyagi, Japan, 980-8574
Tohoku University Hospital
[Recruiting]
Sendai, Miyagi, Japan, 980-8574
Japan, NaganoJapan, Nagano
Shinshu University Hospital
[Not yet recruiting]
Matsumoto, Nagano, Japan, 390-8621
Shinshu University Hospital
[Withdrawn]
Matsumoto, Nagano, Japan, 390-8621
Japan, NaraJapan, Nara
Tenri Hospital
[Not yet recruiting]
Tenri, Nara, Japan, 632-8552
Tenri Hospital
[Recruiting]
Tenri, Nara, Japan, 632-8552
Japan, OsakaJapan, Osaka
Kindai University Hospital
[Not yet recruiting]
Osakasayama, Osaka, Japan, 589-8511
Kindai University Hospital
[Not yet recruiting]
Osakasayama, Osaka, Japan, 589-8511
Japan, SaitamaJapan, Saitama
Saitama Medical University International Medical Center
[Recruiting]
Hidaka, Saitama, Japan, 350-1298
Saitama Medical University International Medical Center
[Recruiting]
Hidaka, Saitama, Japan, 350-1298
Saitama Medical Center
[Recruiting]
Kawagoe, Saitama, Japan, 350-8550
Saitama Medical Center
[Recruiting]
Kawagoe, Saitama, Japan, 350-8550
Japan, ShimaneJapan, Shimane
Shimane University Hospital
[Recruiting]
Izumo, Shimane, Japan, 693-8501
Shimane University Hospital
[Recruiting]
Izumo, Shimane, Japan, 693-8501
Japan, ShizuokaJapan, Shizuoka
Shizuoka Cancer Center
[Not yet recruiting]
Sunto, Shizuoka, Japan, 411-8777
Shizuoka Cancer Center
[Withdrawn]
Sunto, Shizuoka, Japan, 411-8777
Japan, TochigiJapan, Tochigi
Jichi Medical University Hospital
[Withdrawn]
Shimotsuke, Tochigi, Japan, 329-0498
Jichi Medical University Hospital
[Withdrawn]
Shimotsuke, Tochigi, Japan, 329-0498
Japan, TokyoJapan, Tokyo
National Cancer Center Hospital
[Recruiting]
Chuo-ku, Tokyo, Japan, 104-0045
National Cancer Center Hospital
[Recruiting]
Chuo-ku, Tokyo, Japan, 104-0045
Toranomon Hospital
[Not yet recruiting]
Minato-ku, Tokyo, Japan, 105-8470
Toranomon Hospital
[Not yet recruiting]
Minato-ku, Tokyo, Japan, 105-8470
JapanJapan
Aomori Prefectural Central Hospital
[Not yet recruiting]
Aomori, Japan, 030-8553
Aomori Prefectural Central Hospital
[Recruiting]
Aomori, Japan, 030-8553
National Hospital Organization Kyushu Cancer Center
[Recruiting]
Fukuoka, Japan, 811-1395
National Hospital Organization Kyushu Cancer Center
[Recruiting]
Fukuoka, Japan, 811-1395
Hiroshima Red Cross & Atomic-bomb Survivors Hospital
[Recruiting]
Hiroshima, Japan, 730-8619
Hiroshima Red Cross & Atomic-bomb Survivors Hospital
[Recruiting]
Hiroshima, Japan, 730-8619
National Hospital Organization Kumamoto Medical Center
[Not yet recruiting]
Kumamoto, Japan, 860-0008
National Hospital Organization Kumamoto Medical Center
[Recruiting]
Kumamoto, Japan, 860-0008
Kumamoto University Hospital
[Not yet recruiting]
Kumamoto, Japan, 860-8556
Kumamoto University Hospital
[Recruiting]
Kumamoto, Japan, 860-8556
Kyoto Prefectural University of Medicine
[Recruiting]
Kyoto, Japan, 602-8566
Kyoto Prefectural University of Medicine
[Recruiting]
Kyoto, Japan, 602-8566
Niigata Cancer Center Hospital
[Withdrawn]
Niigata, Japan, 951-8566
Niigata Cancer Center Hospital
[Withdrawn]
Niigata, Japan, 951-8566
Osaka Red Cross Hospital
[Not yet recruiting]
Osaka, Japan, 543-8555
Osaka Red Cross Hospital
[Not yet recruiting]
Osaka, Japan, 543-8555
Osaka City University Hospital
[Recruiting]
Osaka, Japan, 545-8586
Osaka City University Hospital
[Recruiting]
Osaka, Japan, 545-8586
Yamagata University Hospital
[Recruiting]
Yamagata, Japan, 990-9585
Yamagata University Hospital
[Recruiting]
Yamagata, Japan, 990-9585
Korea, Republic of, Busan Gwang''yeogsiKorea, Republic of, Busan Gwang''yeogsi
Pusan National University Hospital
[Recruiting]
Busan, Busan Gwang''yeogsi, Korea, Republic of, 49241
Pusan National University Hospital
[Recruiting]
Busan, Busan Gwang''yeogsi, Korea, Republic of, 49241
Korea, Republic ofKorea, Republic of
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 05505
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 05505
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of, 110-744
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University College of Medicine
[Recruiting]
Seoul, Korea, Republic of, 120-752
Severance Hospital, Yonsei University College of Medicine
[Recruiting]
Seoul, Korea, Republic of, 120-752
Mexico, Distrito FederalMexico, Distrito Federal
Hospital General de México SS
[Recruiting]
Ciudad de México, Distrito Federal, Mexico, 06729
Hospital General de México SS
[Recruiting]
Ciudad de México, Distrito Federal, Mexico, 06729
Instituto Nacional de Cancerología
[Withdrawn]
México, Distrito Federal, Mexico, 14080
Instituto Nacional de Cancerología
[Withdrawn]
México, Distrito Federal, Mexico, 14080
Mexico, MichoacánMexico, Michoacán
Centro de Investigación Clínica Chapultepec S.A. de C.V.
[Recruiting]
Morelia, Michoacán, Mexico, 58260
Centro de Investigación Clínica Chapultepec S.A. de C.V.
[Recruiting]
Morelia, Michoacán, Mexico, 58260
Mexico, Nuevo LeonMexico, Nuevo Leon
Hospital Universitario "José Eleuterio González"
[Recruiting]
Monterrey, Nuevo Leon, Mexico, 64460
Hospital Universitario "José Eleuterio González"
[Recruiting]
Monterrey, Nuevo Leon, Mexico, 64460
Mexico, YucatánMexico, Yucatán
Centro de Atencion e Investigacion Clinica en Oncologia SCP
[Recruiting]
Merida, Yucatán, Mexico, 97134
Centro de Atencion e Investigacion Clinica en Oncologia SCP
[Recruiting]
Merida, Yucatán, Mexico, 97134
MexicoMexico
Centro Especializado en Investigación Clínica S.C.
[Recruiting]
Veracruz, Mexico, 94290
Centro Especializado en Investigación Clínica S.C.
[Recruiting]
Veracruz, Mexico, 94290
PolandPoland
Szpital Morski im. PCK
[Recruiting]
Gdynia, Poland, 81-519
Szpital Morski im. PCK
[Recruiting]
Gdynia, Poland, 81-519
Malopolskie Centrum Medyczne
[Recruiting]
Krakow, Poland, 30-510
Malopolskie Centrum Medyczne
[Recruiting]
Krakow, Poland, 30-510
Wojew. Szpital Specjalistyczny im. M. Kopernika
[Withdrawn]
Lodz, Poland, 93-513
Wojew. Szpital Specjalistyczny im. M. Kopernika
[Withdrawn]
Lodz, Poland, 93-513
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
[Withdrawn]
Lublin, Poland, 20-090
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
[Withdrawn]
Lublin, Poland, 20-090
PortugalPortugal
Hospital de Braga
[Recruiting]
Braga, Portugal, 4710-243
Hospital de Braga
[Recruiting]
Braga, Portugal, 4710-243
CHUP, EPE - Hospital de Santo Antonio
[Recruiting]
Porto, Portugal, 4099-001
CHUP, EPE - Hospital de Santo Antonio
[Recruiting]
Porto, Portugal, 4099-001
Instituto Portugues de Oncologia de Francisco Gentil - Porto
[Recruiting]
Porto, Portugal, 4200-072
Instituto Portugues de Oncologia de Francisco Gentil - Porto
[Recruiting]
Porto, Portugal, 4200-072
Centro Hospitalar de S. Joao, EPE Hospital S. Joao
[Recruiting]
Porto, Portugal, 4200-319
Centro Hospitalar de S. Joao, EPE Hospital S. Joao
[Recruiting]
Porto, Portugal, 4200-319
CHVNG/E - Centro Hospitalar de Vila Nova de Gaia/Espinho
[Recruiting]
Vila Nova de Gaia, Portugal, 4434-502
CHVNG/E - Centro Hospitalar de Vila Nova de Gaia/Espinho
[Recruiting]
Vila Nova de Gaia, Portugal, 4434-502
RomaniaRomania
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
[Recruiting]
Baia Mare, Romania, 430031
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
[Recruiting]
Baia Mare, Romania, 430031
S.C. Policlinica de Diagnostic Rapid S.A.
[Not yet recruiting]
Brasov, Romania, 500152
S.C. Policlinica de Diagnostic Rapid S.A.
[Not yet recruiting]
Brasov, Romania, 500152
Fundeni Clinical Institute
[Recruiting]
Bucharest, Romania, 022328
Fundeni Clinical Institute
[Recruiting]
Bucharest, Romania, 022328
Spitalul Clinic Coltea
[Recruiting]
Bucharest, Romania, 030171
Spitalul Clinic Coltea
[Recruiting]
Bucharest, Romania, 030171
Sp. Univ. de Urgenta Militar Central Dr. Carol Davila
[Recruiting]
Bucuresti, Romania, 010825
Sp. Univ. de Urgenta Militar Central Dr. Carol Davila
[Recruiting]
Bucuresti, Romania, 010825
Spitalul Clinic Colentina
[Recruiting]
Bucuresti, Romania, 020125
Spitalul Clinic Colentina
[Recruiting]
Bucuresti, Romania, 020125
Institutul Oncologic Prof. Dr. Ion Chiricuta
[Withdrawn]
Cluj-Napoca, Romania, 400124
Institutul Oncologic Prof. Dr. Ion Chiricuta
[Withdrawn]
Cluj-Napoca, Romania, 400124
Spitalul Clinic Municipal Filantropia Craiova
[Recruiting]
Craiova, Romania, 200143
Spitalul Clinic Municipal Filantropia Craiova
[Recruiting]
Craiova, Romania, 200143
Institutul Regional de Oncologie Iasi
[Recruiting]
Iasi, Romania, 700111
Institutul Regional de Oncologie Iasi
[Recruiting]
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Sibiu
[Not yet recruiting]
Sibiu, Romania, 550245
Spitalul Clinic Judetean de Urgenta Sibiu
[Not yet recruiting]
Sibiu, Romania, 550245
Spitalul Clinic Judetean de Urgenta Targu-Mures
[Recruiting]
Targu-Mures, Romania, 540136
Spitalul Clinic Judetean de Urgenta Targu-Mures
[Recruiting]
Targu-Mures, Romania, 540136
Russian FederationRussian Federation
State budgetary institution of health of the Kaluga region "
[Recruiting]
Kaluga, Russian Federation, 248007
State budgetary institution of health of the Kaluga region "
[Recruiting]
Kaluga, Russian Federation, 248007
Kemerovo Regional Clinical Hospital
[Recruiting]
Kemerovo, Russian Federation, 650066
Kemerovo Regional Clinical Hospital
[Recruiting]
Kemerovo, Russian Federation, 650066
Clinical Oncological Dispensary of Omsk Region
[Recruiting]
Omsk, Russian Federation, 644013
Clinical Oncological Dispensary of Omsk Region
[Recruiting]
Omsk, Russian Federation, 644013
Research Institute of Oncology
[Recruiting]
Rostov-on-Don, Russian Federation, 344037
Research Institute of Oncology
[Recruiting]
Rostov-on-Don, Russian Federation, 344037
RSRI of Hematology and Transfusiology
[Recruiting]
Saint-Petersburg, Russian Federation, 191024
RSRI of Hematology and Transfusiology
[Recruiting]
Saint-Petersburg, Russian Federation, 191024
Oncology Dispensary #2
[Recruiting]
Sochi, Russian Federation, 354057
Oncology Dispensary #2
[Recruiting]
Sochi, Russian Federation, 354057
St. Petersburg Clinical Hospital of RAS
[Withdrawn]
St. Petersburg, Russian Federation, 194017
St. Petersburg Clinical Hospital of RAS
[Withdrawn]
St. Petersburg, Russian Federation, 194017
Siberian State Medical University
[Recruiting]
Tomsk, Russian Federation, 634050
Siberian State Medical University
[Recruiting]
Tomsk, Russian Federation, 634050
Republican Clinical Oncology Dispensary
[Recruiting]
Ufa, Russian Federation, 450054
Republican Clinical Oncology Dispensary
[Recruiting]
Ufa, Russian Federation, 450054
Regional Clinical Hospital
[Recruiting]
Yaroslavl, Russian Federation, 150062
Regional Clinical Hospital
[Recruiting]
Yaroslavl, Russian Federation, 150062
SingaporeSingapore
National University Hospital
[Recruiting]
Singapore, Singapore, 119228
National University Hospital
[Recruiting]
Singapore, Singapore, 119228
National Cancer Center
[Recruiting]
Singapore, Singapore, 169610
National Cancer Center
[Recruiting]
Singapore, Singapore, 169610
Singapore General Hospital
[Recruiting]
Singapore, Singapore, 169856
Singapore General Hospital
[Recruiting]
Singapore, Singapore, 169856
Raffles Hospital
[Recruiting]
Singapore, Singapore, 188770
Raffles Hospital
[Recruiting]
Singapore, Singapore, 188770
SlovakiaSlovakia
Narodny onkologicky ustav
[Recruiting]
Bratislava, Slovakia, 833 10
Narodny onkologicky ustav
[Recruiting]
Bratislava, Slovakia, 833 10
Vychodoslovensky onkologicky ustav a.s.
[Recruiting]
Kosice, Slovakia, 041 91
Vychodoslovensky onkologicky ustav a.s.
[Recruiting]
Kosice, Slovakia, 041 91
South Africa, Eastern CapeSouth Africa, Eastern Cape
Outeniqua Cancercare Oncology Unit
[Recruiting]
George, Eastern Cape, South Africa, 6530
Outeniqua Cancercare Oncology Unit
[Recruiting]
George, Eastern Cape, South Africa, 6530
Cancercare Langenhoven Drive Oncology Centre
[Recruiting]
Port Elizabeth, Eastern Cape, South Africa, 6045
Cancercare Langenhoven Drive Oncology Centre
[Recruiting]
Port Elizabeth, Eastern Cape, South Africa, 6045
South Africa, GautengSouth Africa, Gauteng
Albert Alberts Stem Cell Transplant Research Centre
[Recruiting]
Pretoria, Gauteng, South Africa, 0044
Albert Alberts Stem Cell Transplant Research Centre
[Recruiting]
Pretoria, Gauteng, South Africa, 0044
South Africa, Kwazulu-NatalSouth Africa, Kwazulu-Natal
Department of Oncology
[Withdrawn]
Pietermaritzburg, Kwazulu-Natal, South Africa, 3201
Department of Oncology
[Withdrawn]
Pietermaritzburg, Kwazulu-Natal, South Africa, 3201
South Africa, Western CapeSouth Africa, Western Cape
Constantiaberg Medi Clinic
[Recruiting]
Cape Town, Western Cape, South Africa, 7800
Constantiaberg Medi Clinic
[Recruiting]
Cape Town, Western Cape, South Africa, 7800
Spain, BarcelonaSpain, Barcelona
Institut Català d'Oncologia Badalona
[Recruiting]
Badalona, Barcelona, Spain, 08916
Institut Català d'Oncologia Badalona
[Recruiting]
Badalona, Barcelona, Spain, 08916
Institut Català d'Oncologia Hospitalet
[Recruiting]
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Institut Català d'Oncologia Hospitalet
[Recruiting]
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Spain, MadridSpain, Madrid
Hospital Universitario Clinica Puerta de Hierro
[Recruiting]
Majadahonda, Madrid, Spain, 28222
Hospital Universitario Clinica Puerta de Hierro
[Recruiting]
Majadahonda, Madrid, Spain, 28222
SpainSpain
Complejo Hospitalario Universitario A Coruña
[Recruiting]
A Coruña, Spain, 15006
Complejo Hospitalario Universitario A Coruña
[Recruiting]
A Coruña, Spain, 15006
Ciutat Sanitària i Universitaria de la Vall d'Hebron
[Recruiting]
Barcelona, Spain, 08035
Ciutat Sanitària i Universitaria de la Vall d'Hebron
[Recruiting]
Barcelona, Spain, 08035
Hospital Clínic i Provincial de Barcelona
[Withdrawn]
Barcelona, Spain, 08036
Hospital Clínic i Provincial de Barcelona
[Withdrawn]
Barcelona, Spain, 08036
Hospital Regional de Málaga
[Recruiting]
Málaga, Spain, 29010
Hospital Regional de Málaga
[Recruiting]
Málaga, Spain, 29010
Hospital Clínico Universitario Lozano Blesa
[Recruiting]
Zaragoza, Spain, 50009
Hospital Clínico Universitario Lozano Blesa
[Recruiting]
Zaragoza, Spain, 50009
Switzerland, AargauSwitzerland, Aargau
Kantonsspital Aarau
[Withdrawn]
Aarau, Aargau, Switzerland, 5001
Kantonsspital Aarau
[Withdrawn]
Aarau, Aargau, Switzerland, 5001
Switzerland, Basel-LandschaftSwitzerland, Basel-Landschaft
Kantonsspital Baselland - Standort Liestal
[Withdrawn]
Liestal, Basel-Landschaft, Switzerland, 4410
Kantonsspital Baselland - Standort Liestal
[Withdrawn]
Liestal, Basel-Landschaft, Switzerland, 4410
Switzerland, TicinoSwitzerland, Ticino
Ospedale Regionale Bellinzona
[Recruiting]
Bellinzona, Ticino, Switzerland, 6500
Ospedale Regionale Bellinzona
[Recruiting]
Bellinzona, Ticino, Switzerland, 6500
TaiwanTaiwan
Changhua Christian Hospital
[Recruiting]
Changhua, Taiwan, 500
Changhua Christian Hospital
[Recruiting]
Changhua, Taiwan, 500
Chang Gung Memorial Hospital Kaohsiung
[Recruiting]
Kaohsiung, Taiwan, 833
Chang Gung Memorial Hospital Kaohsiung
[Recruiting]
Kaohsiung, Taiwan, 833
National Cheng Kung University Hospital
[Recruiting]
Tainan, Taiwan, 70428
National Cheng Kung University Hospital
[Recruiting]
Tainan, Taiwan, 70428
National Taiwan University Hospital
[Recruiting]
Taipei, Taiwan, 10002
National Taiwan University Hospital
[Recruiting]
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
[Recruiting]
Taipei, Taiwan, 11217
Taipei Veterans General Hospital
[Recruiting]
Taipei, Taiwan, 11217
ThailandThailand
Pramongkutklao Hospital
[Recruiting]
Bangkok, Thailand, 10400
Pramongkutklao Hospital
[Recruiting]
Bangkok, Thailand, 10400
Siriraj Hospital, Mahidol
[Recruiting]
Bangkok, Thailand, 10700
Siriraj Hospital, Mahidol
[Recruiting]
Bangkok, Thailand, 10700
TurkeyTurkey
Ankara Universitesi Tip Fakultesi Hastanesi
[Recruiting]
Ankara, Turkey, 06100
Ankara Universitesi Tip Fakultesi Hastanesi
[Recruiting]
Ankara, Turkey, 06100
Trakya Univ. Tip Fak.
[Recruiting]
Edirne, Turkey, 22030
Trakya Univ. Tip Fak.
[Recruiting]
Edirne, Turkey, 22030
Istanbul Universitesi Istanbul Tip Fakultesi
[Recruiting]
Istanbul, Turkey, 34093
Istanbul Universitesi Istanbul Tip Fakultesi
[Recruiting]
Istanbul, Turkey, 34093
Marmara Universitesi Tip Fakultesi
[Recruiting]
Istanbul, Turkey, 34662
Marmara Universitesi Tip Fakultesi
[Recruiting]
Istanbul, Turkey, 34662
Ege Universitesi Tip Fakultesi
[Recruiting]
Izmir, Turkey, 35100
Ege Universitesi Tip Fakultesi
[Recruiting]
Izmir, Turkey, 35100
Dokuz Eylul Universitesi Tip Fakultesi
[Recruiting]
Izmir, Turkey, 35340
Dokuz Eylul Universitesi Tip Fakultesi
[Recruiting]
Izmir, Turkey, 35340
Erciyes Universitesi Tip Fakultesi
[Recruiting]
Kayseri, Turkey, 38039
Erciyes Universitesi Tip Fakultesi
[Recruiting]
Kayseri, Turkey, 38039
Ondokuz Mayis Uni Tip Fakultesi
[Recruiting]
Samsun, Turkey, 55139
Ondokuz Mayis Uni Tip Fakultesi
[Recruiting]
Samsun, Turkey, 55139
Karadeniz Technical University Faculty of Medicine
[Recruiting]
Trabzon, Turkey, 61080
Karadeniz Technical University Faculty of Medicine
[Recruiting]
Trabzon, Turkey, 61080
UkraineUkraine
Cherkasy Oncological Dispensary
[Recruiting]
Cherkasy, Ukraine, 18009
Cherkasy Oncological Dispensary
[Recruiting]
Cherkasy, Ukraine, 18009
Multidisciplinary Clinical Hosp. 4 Dnipro
[Recruiting]
Dnipro, Ukraine, 49102
Multidisciplinary Clinical Hosp. 4 Dnipro
[Recruiting]
Dnipro, Ukraine, 49102
National Cancer Institute
[Recruiting]
Kiev, Ukraine, 03022
National Cancer Institute
[Recruiting]
Kiev, Ukraine, 03022
Institute of Blood Pathology and Transfusion medicine
[Recruiting]
Lviv, Ukraine, 79044
Institute of Blood Pathology and Transfusion medicine
[Recruiting]
Lviv, Ukraine, 79044
Zaporizhzhia Regional Clinical Hospital
[Recruiting]
Zaporizhzhya, Ukraine, 69600
Zaporizhzhia Regional Clinical Hospital
[Recruiting]
Zaporizhzhya, Ukraine, 69600
United Kingdom, CornwallUnited Kingdom, Cornwall
Royal Cornwall Hospital
[Recruiting]
Truro, Cornwall, United Kingdom, TR1 3LJ
Royal Cornwall Hospital
[Recruiting]
Truro, Cornwall, United Kingdom, TR1 3LJ
United Kingdom, DevonUnited Kingdom, Devon
Royal Devon & Exeter Hospital
[Recruiting]
Exeter, Devon, United Kingdom, EX2 5AX
Royal Devon & Exeter Hospital
[Recruiting]
Exeter, Devon, United Kingdom, EX2 5AX
United Kingdom, LondonUnited Kingdom, London
Northwick Park Hospital
[Recruiting]
Harrow, London, United Kingdom, HA1 3UJ
Northwick Park Hospital
[Recruiting]
Harrow, London, United Kingdom, HA1 3UJ
United Kingdom, SurreyUnited Kingdom, Surrey
Royal Marsden NHS Trust (Surrey)
[Recruiting]
Sutton, Surrey, United Kingdom, SM2 5PT
Royal Marsden NHS Trust (Surrey)
[Recruiting]
Sutton, Surrey, United Kingdom, SM2 5PT
United Kingdom, Tyne And WearUnited Kingdom, Tyne And Wear
Freeman Hospital
[Withdrawn]
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Freeman Hospital
[Withdrawn]
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
United KingdomUnited Kingdom
Dorset County Hospital
[Recruiting]
Dorchester, United Kingdom, DT1 2JY
Dorset County Hospital
[Recruiting]
Dorchester, United Kingdom, DT1 2JY
St. George's Hospital
[Recruiting]
London, United Kingdom, SW17 OQT
St. George's Hospital
[Recruiting]
London, United Kingdom, SW17 OQT
Royal Marsden Hospital (London)
[Recruiting]
London, United Kingdom, SW3 6JJ
Royal Marsden Hospital (London)
[Recruiting]
London, United Kingdom, SW3 6JJ
Manchester Royal Infirmary
[Withdrawn]
Manchester, United Kingdom, M13 9WL
Manchester Royal Infirmary
[Withdrawn]
Manchester, United Kingdom, M13 9WL
Singleton Hospital
[Recruiting]
Swansea, United Kingdom, SA2 8QA
Singleton Hospital
[Recruiting]
Swansea, United Kingdom, SA2 8QA
VietnamVietnam
[Withdrawn]
Hanoi, Vietnam
[Withdrawn]
Hanoi, Vietnam
[Withdrawn]
Ho Chi Minh City, Vietnam
[Withdrawn]
Ho Chi Minh City, Vietnam
IPDSharing
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References
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Available IPD/Information:

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