CHRONOS-2: Phase III Copanlisib in Rituximab-refractory iNHL
Study Details
Study Description
Brief Summary
To assess the safety of copanlisib.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Copanlisib (BAY 80-6946) patients with rituximab-refractory iNHL |
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
|
Outcome Measures
Primary Outcome Measures
- Number of patients with treatment-emergent adverse events [Up to 3 years]
- Number of patients with serious adverse events [Up to 3 years]
- Number of patients with abnormal lab parameters [Up to 3 years]
- Number of patients with abnormal vital signs [Up to 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
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Follicular lymphoma (FL) grade 1-2-3a.
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Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10*9/L at the time of diagnosis and at study entry.
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Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
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Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal).
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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.
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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.
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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.
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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.
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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.
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ECOG performance status ≤ 1
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Adequate bone marrow, liver and renal function
Exclusion Criteria:
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Histologically confirmed diagnosis of FL grade 3b.
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Chronic lymphocytic leukemia (CLL).
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Transformed disease (assessed by investigator):
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histological confirmation of transformation, or
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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).
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Bulky disease - Lymph nodes or tumor mass (except spleen) >= 7cm LD (longest diameter)
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Known lymphomatous involvement of the central nervous system.
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Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment).
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Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
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Known history of human immunodeficiency virus (HIV) infection.
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Active clinically serious infections > CTCAE Grade 2
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Active Hepatitis B or hepatitis C
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History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
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History of having received an allogeneic bone marrow or organ transplant
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Positive cytomegalovirus (CMV) PCR test at baseline
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Pregnant or breast-feeding patients
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jaú | Sao Paulo | Brazil | 17210-120 | |
2 | São Paulo | Sao Paulo | Brazil | 08270-120 | |
3 | Sao Paulo | Brazil | |||
4 | Plovdiv | Bulgaria | 4002 | ||
5 | Athens | Greece | 115 26 | ||
6 | Bologna | Emilia-Romagna | Italy | 40138 | |
7 | Genova | Liguria | Italy | 16132 | |
8 | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 03080 | |
9 | Jeollabuk-do | Korea, Republic of | 561-712 | ||
10 | Jeollanam-do | Korea, Republic of | 58128 | ||
11 | Seoul | Korea, Republic of | 03722 | ||
12 | Seoul | Korea, Republic of | 05505 | ||
13 | Gdynia | Poland | 81-519 | ||
14 | Kazan | Russian Federation | 420029 | ||
15 | Kemerovo | Russian Federation | 650066 | ||
16 | Moscow | Russian Federation | 123182 | ||
17 | Omsk | Russian Federation | 644013 | ||
18 | Penza | Russian Federation | 440071 | ||
19 | Johannesburg | Gauteng | South Africa | 2013 | |
20 | Taipei | Taiwan | 100 | ||
21 | Istanbul | Turkey | 34093 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17322
- 2014-000925-19