Trials / Terminated
TerminatedNCT04745832
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- MEI Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zandelisib | Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 |
| DRUG | Rituximab | Rituximab IV 375 mg/m2 for 6 cycles |
| DRUG | Bendamustine | Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles |
| DRUG | CHOP | Cyclophosphamide, Vindcristine IV, and Prednisone daily orally |
Timeline
- Start date
- 2021-08-13
- Primary completion
- 2023-03-20
- Completion
- 2023-03-20
- First posted
- 2021-02-09
- Last updated
- 2024-11-04
- Results posted
- 2023-12-13
Locations
141 sites across 19 countries: United States, Australia, Belgium, Canada, France, Georgia, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04745832. Inclusion in this directory is not an endorsement.