Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Follicular Lymphoma ( FL)
- Marginal Zone Lymphoma
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm 1: Rituximab plus Zandelisib Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP). Subjects must have relapsed...
This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP). Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L). Approximately 534 randomized subjects will be enrolled in this study.
Tracking Information
- NCT #
- NCT04745832
- Collaborators
- Kyowa Kirin
- Investigators
- Not Provided
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