Description:
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.
Title
- Brief Title: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
- 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
Clinical Trial IDs
- ORG STUDY ID:
ME-401-004
- SECONDARY ID:
2020-004199-16
- NCT ID:
NCT04745832
Conditions
- Follicular Lymphoma (FL)
- Non Hodgkin Lymphoma
- Marginal Zone Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Zandelisib | ME-401 | Rituximab plus Zandelisib |
Rituximab | Rituxan, MabThera | Rituximab plus Zandelisib |
Bendamustine | Bendeka, Treanda, Belrapzo | Rituximab plus chemotherapy |
CHOP | cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily | Rituximab plus chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Rituximab plus Zandelisib | Experimental | Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles | |
Rituximab plus chemotherapy | Experimental | Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles | - Rituximab
- Bendamustine
- CHOP
|
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for
subjects in Japan and Taiwan
- Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype
limited to:
1. FL Gr 1, Gr 2, or Gr 3a
2. MZL (splenic, nodal, or extra-nodal)
- Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
- Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
- Adequate hematologic parameters at screening unless abnormal values are due to disease
- Adequate renal and hepatic function
- Adequate cardiac function based on ECG and LVEF assessments
Exclusion Criteria:
- Histologically confirmed diagnosis of FL Gr 3b or transformed disease
- Prior therapy with PI3K inhibitors
- Ongoing or history of drug-induced pneumonitis
- Known lymphomatous involvement of the central nervous system
- Tested positive for or active viral infection with hepatitis B or C virus
- Tested positive or active infection with human immunodeficiency virus
- Tested positive, or active infection with human T-cell leukemia virus type 1
- Any uncontrolled clinically significant illness
- History of clinically significant cardiovascular abnormalities such as congestive
heart failure
- History of clinically significant gastrointestinal (GI) conditions
- Females who are pregnant
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | PFS is defined as the time from randomization date until the date of disease progression, or death from any cause |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Complete Response Rate (CRR) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | 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). |
Measure: | Overall Survival |
Time Frame: | 10 years |
Safety Issue: | |
Description: | 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. |
Measure: | Number of Treatment Emergent AEs (Zandelisib when combined with Rituximab) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measured by the number of Treatment Emergent AEs |
Measure: | Number of SAEs (Zandelisib when combined with Rituximab) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measured by the number of SAEs |
Measure: | Number of Lab Abnormalities (Zandelisib when combined with Rituximab) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measured by the number of laboratory abnormalities |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | MEI Pharma, Inc. |
Last Updated
August 2, 2021