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Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4)

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ClinicalTrials.gov Identifier: NCT02626455
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Copanlisib (BAY80-6946) Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Bendamustine Drug: Prednisone Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 6, 2016
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Copanlisib

Arm Intervention/treatment
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




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 [ Time Frame: 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) [ Time Frame: Up to 52 months ]
    Progression free survival is defined as the time (in days) from randomization to disease progression or death from any cause (if no progression documented).


Secondary Outcome Measures :
  1. Safety run-in_Best Overall Response (BOR) [ Time Frame: After Cycle 1: Up to 12 months ]
  2. Safety run-in_Number of participants with treatment-emergent adverse events [ Time Frame: Up to 13 months ]
  3. Phase III_Objective tumor response rate (ORR) [ Time Frame: Up to 52 months ]
    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).

  4. Phase III_Duration of tumor response (DOR) [ Time Frame: Up to 52 months ]
    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.

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

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

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

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

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

    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.


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

    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.


  11. Phase III_Number of participants with treatment-emergent adverse events [ Time Frame: Up to 52 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626455


Contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

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United States, Alaska
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Anchorage, Alaska, United States, 99503
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Chandler, Arizona, United States, 85224
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Maywood, Illinois, United States, 60153
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Middletown, New Jersey, United States, 07748
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Montvale, New Jersey, United States, 07645
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Morristown, New Jersey, United States, 07962-1956
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Westwood, New Jersey, United States, 07675
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New York, New York, United States, 10065
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Nyack, New York, United States, 19060
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Rockville Centre, New York, United States, 11570
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Greenville, North Carolina, United States, 27858
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Columbus, Ohio, United States, 43219
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Watertown, South Dakota, United States, 57201
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77030
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Laredo, Texas, United States, 78041
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Lubbock, Texas, United States, 79410
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Lubbock, Texas, United States, 79415
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Olympia, Washington, United States, 98502
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Darlinghurst, New South Wales, Australia, 2010
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Benowa, Queensland, Australia, 4217
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Brisbane, Queensland, Australia, 4029
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Adelaide, South Australia, Australia, 5042
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Kurralta Park, South Australia, Australia, 5037
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Frankston, Victoria, Australia, 3199
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Prahran, Victoria, Australia, 3181
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Murdoch, Western Australia, Australia, 6150
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Box Hill, Australia, 3128
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Wels, Austria, 4600
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GZA Ziekenhuizen Recruiting
Wilrijk, Antwerpen, Belgium, 2610
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Kortrijk, West-Vlaanderen, Belgium, 8500
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Bruxelles - Brussel, Belgium, 1000
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Curitiba, Parana, Brazil, 80810-050
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Lajeado, Rio Grande Do Sul, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
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Porto Alegre, Rio Grande Do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil, 88034-000
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Campinas, Sao Paulo, Brazil, 130839 970
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Santo Andre, Sao Paulo, Brazil
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São Paulo, Sao Paulo, Brazil, 01236-030
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São Paulo, Sao Paulo, Brazil, 05403-000.
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São Paulo, Sao Paulo, Brazil, 08.270-070
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Rio de Janeiro, Brazil, 20230 130
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Sao Paulo, Brazil, 05651-901
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UMHAT Sveti Georgi Recruiting
Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1756
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Vratsa, Bulgaria, 3000
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Quebec City, Quebec, Canada, G1J 1Z4
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Temuco, Araucanía, Chile, 4810469
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Viña del Mar, Valparaíso, Chile, 2540364
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Santiago, Chile, 7500921
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Santiago, Chile, 7520378
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Santiago, Chile, 838-0455
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Fuzhou, Fujian, China, 350001
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Guangzhou, Guangdong, China, 510060
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Guangzhou, Guangdong, China, 510100
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Zhengzhou, Henan, China, 450008
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Nanjing, Jiangsu, China, 210009
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Suzhou, Jiangsu, China, 215006
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Xi'an, Shaanxi, China, 710038
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Qingdao, Shandong, China, 266500
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Chengdu, Sichuan, China, 610041
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Hangzhou, Zhejiang, China, 310003
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Hangzhou, Zhejiang, China, 310022
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Beijing, China, 100021
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, China, 100050
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Beijing, China, 100071
Jilin Cancer Hospital Recruiting
Changchun, China, 130012
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Shanghai, China, 200030
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Shanghai, China, 200092
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Shanghai, China, 200123
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Shijiazhuang, China, 050011
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Tianjin, China, 300060
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Tianjin, China, 300121
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Hradec Kralove, Czechia, 50005
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Praha 10, Czechia, 100 34
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H:S Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Odense Universitetshospital Recruiting
Odense C, Denmark, DK-5000
Finland
HUS, Meilahden sairaala Recruiting
Helsinki, Finland, 00290
Keski-Suomen keskussairaala Recruiting
Jyväskylä, Finland, 40620
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Oulu, Finland, 90020
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Tampere, Finland, 33521
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Turku, Finland, 20520
France
Centre Hospitalier Universitaire - Angers Recruiting
Angers, France, 49933
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Bayonne, France, 64100
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Caen Cedex, France, 14033
Hôpital Henri Mondor Recruiting
Creteil, France, 94010
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Grenoble, France, 38043
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Limoges Cedex, France, 87042
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Lyon Cedex, France, 69008
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Montpellier Cedex, France, 34295
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Nantes Cedex, France, 44093
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Paris, France, 75010
Centre François Magendie - Pessac Recruiting
Pessac, France, 33600
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Hôpital de la Milétrie Recruiting
Poitiers, France, 86021
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Centre René Gauducheau - Nantes Withdrawn
Saint Herblain, France, 44805
Clinique Saint Anne Recruiting
Strasbourg, France, 67000
Germany
Stauferklinikum Schwäbisch-Gmünd Recruiting
Mutlangen, Baden-Württemberg, Germany, 73557
Gemeinschaftspraxis Dr.Brudler/ Dr.Heinrich/ Prof.Bangerter Recruiting
Augsburg, Bayern, Germany, 86150
Klinikum der Universität München Grosshadern Recruiting
München, Bayern, Germany, 81377
MVZ Praxis Pihusch GbR Recruiting
Rosenheim, Bayern, Germany, 83022
Universität Rostock - Medizinische Fakultät Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Medizinische Hochschule Hannover (MHH) Recruiting
Hannover, Niedersachsen, Germany, 30625
Onkolog. Gemeinschaftspraxis Dres. D.Reichert & J.Janssen Recruiting
Westerstede, Niedersachsen, Germany, 26655
Marienhospital Herne Universitätsklinik Recruiting
Herne, Nordrhein-Westfalen, Germany, 44625
Universitätsklinikum Münster (UKM) Recruiting
Münster, Nordrhein-Westfalen, Germany, 48149
Oncologianova GmbH Recruiting
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg Recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06097
Greece
Evangelismos General Hospital of Athens Recruiting
Athens, Greece, 106 76
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 Larissa Recruiting
Larissa, Greece, 41100
University General Hospital of Patras Recruiting
Patras, Greece, 26500
G. Papanikolaou General Hospital of Thessaloniki Withdrawn
Thessaloniki, Greece, 57010
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Tuen Mun Hospital Recruiting
Hongkong, Hong Kong
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet Recruiting
Budapest, Hungary, 1122
Semmelweis University Recruiting
Budapest, Hungary, 1125
Somogy Megyei Kaposi Mor Oktato Korhaz Recruiting
Kaposvar, Hungary, 7400
Bacs-Kiskun Country Hospital Withdrawn
Kecskemét, Hungary, 6000
SzSzBMK es EOK Josa Andras Oktatokorhaz Recruiting
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, 7624
Szent Borbala Hospital Recruiting
Tatabanya, Hungary, 2800
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Misericordiae Hospital Recruiting
Dublin, Ireland, 7
St James's Hospital Withdrawn
Dublin, Ireland
Israel
Rambam Health Corporation Recruiting
Haifa, Israel, 3109601
Edith Wolfson Medical Center Withdrawn
Holon, Israel, 5810001
Hadassah Hebrew University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 9112001
Meir Medical Center Withdrawn
Kfar Saba, Israel, 4428164
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262000
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 6093000
Italy
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim Recruiting
Bologna, Emilia-Romagna, Italy, 40138
AUSL della Romagna Not yet recruiting
Ravenna, Emilia-Romagna, Italy, 48121
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro Recruiting
Genova, Liguria, Italy, 16132
IRCCS Istituto Clinico Humanitas (ICH) Recruiting
Milano, Lombardia, Italy, 20089
IRCCS Istituto Europeo di Oncologia Not yet recruiting
Milano, Lombardia, Italy, 20141
IRCCS Fondazione Policlinico San Matteo Recruiting
Pavia, Lombardia, Italy, 27100
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Recruiting
Ancona, Marche, Italy, 60100
Japan
National Hospital Organization Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital Not yet recruiting
Nagoya, Aichi, Japan, 464-8681
Japanese Red Cross Nagoya Daini Hospital Not yet recruiting
Nagoya, Aichi, Japan, 466-8650
Nagoya City University Hospital Recruiting
Nagoya, Aichi, Japan, 467-8602
JCHO Kyushu Hospital Not yet recruiting
Kitakyushu, Fukuoka, Japan, 806-8501
Kurume University Hospital Not yet recruiting
Kurume, Fukuoka, Japan, 830-0011
Gunma University Hospital Recruiting
Maebashi, Gunma, Japan, 371-8511
Hyogo Cancer Center Not yet recruiting
Akashi, Hyogo, Japan, 673-8558
Kobe University Hospital Recruiting
Kobe, Hyogo, Japan, 650-0017
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 980-8574
Shinshu University Hospital Not yet recruiting
Matsumoto, Nagano, Japan, 390-8621
Kindai University Hospital Not yet recruiting
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center Not yet recruiting
Hidaka, Saitama, Japan, 350-1298
Shimane University Hospital Not yet recruiting
Izumo, Shimane, Japan, 693-8501
Jichi Medical University Hospital Not yet recruiting
Shimotsuke, Tochigi, Japan, 329-0498
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Toranomon Hospital Not yet recruiting
Minato-ku, Tokyo, Japan, 105-8470
Aomori Prefectural Central Hospital Not yet recruiting
Aomori, Japan, 030-8553
National Hospital Organization Kyushu Cancer Center Not yet recruiting
Fukuoka, Japan, 811-1395
National Hospital Organization Kumamoto Medical Center Not yet recruiting
Kumamoto, Japan, 860-0008
Kumamoto University Hospital Not yet recruiting
Kumamoto, Japan, 860-8556
Kyoto Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Niigata Cancer Center Hospital Not yet recruiting
Niigata, Japan, 951-8566
Osaka City University Hospital Not yet recruiting
Osaka, Japan, 545-8586
Yamagata University Hospital Recruiting
Yamagata, Japan, 990-9585
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Busan Gwang''yeogsi, Korea, Republic of, 49241
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
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
Mexico
Hospital General de México SS Not yet recruiting
Ciudad de México, Distrito Federal, Mexico, 06729
Instituto Nacional de Cancerología Not yet recruiting
México, Distrito Federal, Mexico, 14080
Centro de Investigación Clínica Chapultepec S.A. de C.V. Recruiting
Morelia, Michoacán, Mexico, 58260
Hospital Universitario "José Eleuterio González" Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Centro de Atencion e Investigacion Clinica en Oncologia SCP Recruiting
Merida, Yucatán, Mexico, 97134
Centro Especializado en Investigación Clínica S.C. Recruiting
Veracruz, Mexico, 94290
Poland
Szpital Morski im. PCK Recruiting
Gdynia, Poland, 81-519
Malopolskie Centrum Medyczne Recruiting
Krakow, Poland, 30-510
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
Portugal
Hospital de Braga Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio Recruiting
Porto, Portugal, 4099-001
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
CHVNG/E - Centro Hospitalar de Vila Nova de Gaia/Espinho Recruiting
Vila Nova de Gaia, Portugal, 4434-502
Romania
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare Not yet recruiting
Baia Mare, Romania, 430031
S.C. Policlinica de Diagnostic Rapid S.A. Not yet recruiting
Brasov, Romania, 500152
Fundeni Clinical Institute Not yet recruiting
Bucharest, Romania, 022328
Spitalul Clinic Coltea Not yet recruiting
Bucharest, Romania, 030171
Sp. Univ. de Urgenta Militar Central Dr. Carol Davila Not yet recruiting
Bucuresti, Romania, 010825
Spitalul Clinic Colentina Not yet recruiting
Bucuresti, Romania, 020125
Institutul Oncologic Prof. Dr. Ion Chiricuta Not yet recruiting
Cluj-Napoca, Romania, 400015
Spitalul Clinic Municipal Filantropia Craiova Not yet recruiting
Craiova, Romania, 200143
Institutul Regional de Oncologie Iasi Not yet recruiting
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Targu-Mures Not yet recruiting
Targu-Mures, Romania, 540136
Russian Federation
State budgetary institution of health of the Kaluga region " Recruiting
Kaluga, Russian Federation, 248007
Kemerovo Regional Clinical Hospital Recruiting
Kemerovo, Russian Federation, 650066
Clinical Oncological Dispensary of Omsk Region Recruiting
Omsk, Russian Federation, 644013
Research Institute of Oncology Recruiting
Rostov-on-Don, Russian Federation, 344037
Russian Scientific-Research Institute of Hematology and Tran Recruiting
Saint-Petersburg, Russian Federation, 191024
Oncology Dispensary #2 Recruiting
Sochi, Russian Federation, 354057
St. Petersburg Clinical Hospital of RAS Withdrawn
St. Petersburg, Russian Federation, 194017
Siberian State Medical University Recruiting
Tomsk, Russian Federation, 634050
Republican Clinical Oncology Dispensary Recruiting
Ufa, Russian Federation, 450054
Regional Clinical Hospital Recruiting
Yaroslavl, Russian Federation, 150062
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
National Cancer Center Recruiting
Singapore, Singapore, 169610
Singapore General Hospital Recruiting
Singapore, Singapore, 169856
Raffles Hospital Recruiting
Singapore, Singapore, 188770
Slovakia
Narodny onkologicky ustav Recruiting
Bratislava, Slovakia, 833 10
Vychodoslovensky onkologicky ustav a.s. Recruiting
Kosice, Slovakia, 041 91
South Africa
Outeniqua Cancercare Oncology Unit Recruiting
George, Eastern Cape, South Africa, 6530
Cancercare Langenhoven Drive Oncology Centre Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Albert Alberts Stem Cell Transplant Research Centre Recruiting
Pretoria, Gauteng, South Africa, 0044
Department of Oncology Withdrawn
Pietermaritzburg, Kwazulu-Natal, South Africa, 3201
Constantiaberg Medi Clinic Recruiting
Cape Town, Western Cape, South Africa, 7800
Spain
Institut Català d'Oncologia Badalona Recruiting
Badalona, Barcelona, Spain, 08916
Institut Català d'Oncologia Hospitalet Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Clinica Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Ciutat Sanitària i Universitaria de la Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clínic i Provincial de Barcelona Withdrawn
Barcelona, Spain, 08036
Hospital Regional de Málaga Recruiting
Málaga, Spain, 29010
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5001
Kantonsspital Baselland - Standort Liestal Recruiting
Liestal, Basel-Landschaft, Switzerland, 4410
Ospedale Regionale Bellinzona Recruiting
Bellinzona, Ticino, Switzerland, 6500
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 500
Chang Gung Memorial Hospital Kaohsiung Recruiting
Kaohsiung, Taiwan, 833
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70428
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Thailand
Pramongkutklao Hospital Recruiting
Bangkok, Thailand, 10400
Siriraj Hospital, Mahidol Recruiting
Bangkok, Thailand, 10700
Turkey
Ankara Universitesi Tip Fakultesi Hastanesi Recruiting
Ankara, Turkey, 06100
Trakya Univ. Tip Fak. Recruiting
Edirne, Turkey, 22030
Istanbul Universitesi Istanbul Tip Fakultesi Recruiting
Istanbul, Turkey, 34093
Marmara Universitesi Tip Fakultesi Recruiting
Istanbul, Turkey, 34662
Ege Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 35100
Dokuz Eylul Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 35340
Erciyes Universitesi Tip Fakultesi Recruiting
Kayseri, Turkey, 38039
Ondokuz Mayis Uni Tip Fakultesi Recruiting
Samsun, Turkey, 55139
Karadeniz Technical University Faculty of Medicine Recruiting
Trabzon, Turkey, 61080
Ukraine
Cherkasy Oncological Dispensary Recruiting
Cherkasy, Ukraine, 18009
Multidisciplinary Clinical Hosp. 4 Dnipro Not yet recruiting
Dnipro, Ukraine, 49102
National Cancer Institute Recruiting
Kiev, Ukraine, 03022
Institute of Blood Pathology and Transfusion medicine Recruiting
Lviv, Ukraine, 79044
Zaporizhzhia Regional Clinical Hospital Recruiting
Zaporizhzhya, Ukraine, 69600
United Kingdom
Royal Cornwall Hospital Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Royal Devon & Exeter Hospital Recruiting
Exeter, Devon, United Kingdom, EX2 5AX
Northwick Park Hospital Recruiting
Harrow, London, United Kingdom, HA1 3UJ
Royal Marsden NHS Trust (Surrey) Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Freeman Hospital Withdrawn
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Dorset County Hospital Recruiting
Dorchester, United Kingdom, DT1 2JY
St. Georges Hospital Recruiting
London, United Kingdom, SW17 OQT
Royal Marsden Hospital (London) Recruiting
London, United Kingdom, SW3 6JJ
Manchester Royal Infirmary Withdrawn
Manchester, United Kingdom, M13 9WL
Singleton Hospital Recruiting
Swansea, United Kingdom, SA2 8QA
Vietnam
Withdrawn
Hanoi, Vietnam
Withdrawn
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02626455     History of Changes
Other Study ID Numbers: 17833
2015-001088-38 ( EudraCT Number )
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Bendamustine Hydrochloride
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids