A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study
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- STATUS
- Recruiting
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- End date
- Sep 16, 2031
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- participants needed
- 534
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- sponsor
- MEI Pharma, Inc.
Summary
This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
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 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.
Details
| Condition | Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma |
|---|---|
| Treatment | Rituximab, CHOP, Bendamustine, Zandelisib |
| Clinical Study Identifier | NCT04745832 |
| Sponsor | MEI Pharma, Inc. |
| Last Modified on | 16 October 2022 |
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