Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
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|ClinicalTrials.gov Identifier: NCT04745832|
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : November 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma (FL) Non Hodgkin Lymphoma Marginal Zone Lymphoma||Drug: Zandelisib Drug: Rituximab Drug: Bendamustine Drug: CHOP||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||534 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Arm 1: Rituximab plus Zandelisib
Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 13, 2021|
|Estimated Primary Completion Date :||April 2026|
|Estimated Study Completion Date :||September 2031|
Experimental: Rituximab plus Zandelisib
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
Other Name: ME-401
Rituximab IV 375 mg/m2 for 6 cycles
Experimental: Rituximab plus chemotherapy
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
Rituximab IV 375 mg/m2 for 6 cycles
Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
Other Name: Bendeka, Treanda, Belrapzo
Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Other Name: cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily
- Progression Free Survival [ Time Frame: 5 years ]PFS is defined as the time from randomization date until the date of disease progression, or death from any cause
- Overall Response Rate (ORR) [ Time Frame: 5 years ]ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.
- Complete Response Rate (CRR) [ Time Frame: 5 years ]CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).
- Overall Survival [ Time Frame: 10 years ]OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date.
- Number of Treatment Emergent AEs (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]Measured by the number of Treatment Emergent AEs
- Number of SAEs (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]Measured by the number of SAEs
- Number of Lab Abnormalities (Zandelisib when combined with Rituximab) [ Time Frame: 5 years ]Measured by the number of laboratory abnormalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745832
|Contact: Oana Adam||+40 37 email@example.com|
|Contact: MEI Pharmafirstname.lastname@example.org|