Phase III Copanlisib in Rituximab-refractory iNHL
- Registration Number
- NCT02369016
- Lead Sponsor
- Bayer
- Brief Summary
To assess the safety of copanlisib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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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).
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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
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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):
- 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).
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Copanlisib (BAY 80-6946) Copanlisib (BAY 80-6946) patients with rituximab-refractory iNHL
- Primary Outcome Measures
Name Time Method Number of Participants With Abnormal Vital Signs up to 7 years - Reported as TEAEs - worst CTCAE grade total -
Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)s up to 7 years Serious adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
Number of Participants With Abnormal Laboratory Parameters up to 7 years - Above threshold of 10% and reported as TEAEs - any event (Grade 1-4)
Number of Participants With Treatment-emergent Adverse Events (TEAE)s up to 7 years Adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
- Secondary Outcome Measures
Name Time Method