"A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL) "

  • STATUS
    Recruiting
  • sponsor
    Bayer
Updated on 25 March 2021
Research Center (2.8 mi away) Contact

Summary

"A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL) "

Description

The purpose of this study is to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab. Purpose of the study is also to evaluate the safety and tolerability of copanlisib. Approximately 567 patients will be randomly assigned in in blinded treatment arms copanlisib plus rituximab or placebo plus rituximab.

Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo dosing will be administered on the same days as copanlisib.

Rituximab dose is administered weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9. The maximum administration of rituximab is 8 times.

Copanlisib or placebo treatment will be continued until disease progression, unacceptable toxicity, or until another criterion is met for withdrawal from the study treatment.

Following the end of treatment visit, patients will enter either the Safety follow-up or the Active follow-up period.

The efficacy is measured by duration of progression-free survival (time between randomization and onset of a further progression of disease, or death from any cause). Progression of disease will be determined by radiologic tumor assessments to be performed at screening, as well as during the active follow up period tumor assessments every 8 weeks during Year 1, every 12 weeks during Year 2, and every 24 weeks during Year 3.

Blood samples will be collected for safety analysis and pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis and for central pathology review, fresh biopsy tissue and bone marrow will be collected but not mandatory.

For Study Locations, Click Here

For more information, please contact:
844.229.3710
646.776.7532 (local)
Bayer@emergingmed.com

For Study Locations, Click Here

Details
Clinical Study IdentifierTX153140
SponsorBayer
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of CD20 positive Indolent non-Hodgkin's lymphoma (iNHL) with histological subtype limited to
Follicular lymphoma grade1-2-3a
Small lymphocytic lymphoma with absolute lymphocyte count < 5x109/L at the time of diagnosis and at study entry
Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
Marginal zone lymphoma (splenic, nodal, or extra-nodal)
Patients must have relapsed (recurrence after complete response or presented progression after partial response) after at least 1 prior line of therapy, including rituximab. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K (except to copanlisib) is acceptable provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible
Non-WM must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification
Patients affected by W M 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
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 collected no more than 7 days before starting study treatment
Left ventricular ejection fraction ≥ 45%
Patients must either have had a treatment-free interval of at least 12 months after completion of the last rituximab-containing treatment OR be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments or unwillingness to receive chemotherapy

Exclusion Criteria

Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia
Progression free interval or treatment free interval of less than 12 months since the last rituximab containing treatment (including rituximab maintenance). For patients considered unfit to receive chemotherapy : progression free interval or treatment free interval of less than 6 months since the last rituximab containing treatment (including rituximab maintenance), as assessed by the investigator
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
Known lymphomatous involvement of the central nervous system
Patients with HbA1c > 8.5% at Screening
Known history of human immunodeficiency virus (HIV) infection
Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors
Prior treatment with copanlisib
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible
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