Phase III Copanlisib in Rituximab-refractory iNHL (CHRONOS-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02369016 |
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Recruitment Status :
Active, not recruiting
First Posted : February 23, 2015
Last Update Posted : December 10, 2018
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief Summary:
To assess the safety of copanlisib
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin | Drug: Copanlisib (BAY 80-6946) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind Phase III Study of Copanlisib Versus Placebo in Patients With Rituximab-refractory Indolent Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-2 |
| Actual Study Start Date : | September 22, 2015 |
| Estimated Primary Completion Date : | December 20, 2019 |
| Estimated Study Completion Date : | December 20, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Copanlisib (BAY 80-6946)
patients with rituximab-refractory iNHL
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Drug: Copanlisib (BAY 80-6946)
60 mg of experimental drug in solution administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle |
Primary Outcome Measures :
- Number of patients with treatment-emergent adverse events [ Time Frame: Up to 3 years ]
- Number of patients with serious adverse events [ Time Frame: Up to 3 years ]
- Number of patients with abnormal lab parameters [ Time Frame: Up to 3 years ]
- Number of patients with abnormal vital signs [ Time Frame: Up to 3 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
- Follicular lymphoma (FL) grade 1-2-3a.
- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10*9/L at the time of diagnosis and at study entry.
- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal).
- Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.
- Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
- Patients must be refractory to the last rituximab-based treatment, defined as no response or response lasting < 6 months after completion of treatment. Time interval to assess refractoriness will be calculated between the end date (last day) of the last rituximab-containing regimen and the day of diagnosis confirmation of the subsequent relapse.
- Patients must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
- 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 (ULN)and positive immunofixation test.
- ECOG performance status ≤ 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Histologically confirmed diagnosis of FL grade 3b.
- Chronic lymphocytic leukemia (CLL).
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Transformed disease (assessed by investigator):
- histological confirmation of transformation, or
- clinical and laboratory signs: rapid disease progression, high standardized uptake value (SUV) (> 12) by positron emission tomography (PET) at baseline if PET scans are performed (optional).
- Bulky disease - Lymph nodes or tumor mass (except spleen) >= 7cm LD (longest diameter)
- Known lymphomatous involvement of the central nervous system.
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment).
- Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
- Known history of human immunodeficiency virus (HIV) infection.
- Active clinically serious infections > CTCAE Grade 2
- Active Hepatitis B or hepatitis C
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
- History of having received an allogeneic bone marrow or organ transplant
- Positive cytomegalovirus (CMV) PCR test at baseline
- Pregnant or breast-feeding patients
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): NCT02369016
Locations
| Brazil | |
| Jaú, Sao Paulo, Brazil, 17210-120 | |
| São Paulo, Sao Paulo, Brazil, 08270-070 | |
| Sao Paulo, Brazil | |
| Bulgaria | |
| Plovdiv, Bulgaria, 4002 | |
| China, Heilongjiang | |
| Harbin, Heilongjiang, China | |
| France | |
| France, France | |
| Greece | |
| Athens, Greece, 11526 | |
| Italy | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Genova, Liguria, Italy, 16132 | |
| Korea, Republic of | |
| Jeollabuk-do, Korea, Republic of, 561-712 | |
| Jeollanam-do, Korea, Republic of, 519-763 | |
| Seoul, Korea, Republic of, 03080 | |
| Seoul, Korea, Republic of, 03722 | |
| Seoul, Korea, Republic of, 05505 | |
| Poland | |
| Gdynia, Poland, 81-519 | |
| Portugal | |
| Almada, Portugal, 2801-951 | |
| Russian Federation | |
| Kazan, Russian Federation, 420029 | |
| Kemerovo, Russian Federation, 650066 | |
| Moscow, Russian Federation, 123182 | |
| Omsk, Russian Federation, 644013 | |
| Penza, Russian Federation, 440071 | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 2013 | |
| Taiwan | |
| Taipei, Taiwan, 10002 | |
| Turkey | |
| Istanbul, Turkey, 34093 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT02369016 History of Changes |
| Other Study ID Numbers: |
17322 2014-000925-19 ( EudraCT Number ) |
| First Posted: | February 23, 2015 Key Record Dates |
| Last Update Posted: | December 10, 2018 |
| Last Verified: | December 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Bayer:
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indolent Non-Hodgkin lymphoma rituximab-refractory |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |