Overview
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Status:
Recruiting
Recruiting
Trial end date:
2031-09-01
2031-09-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
MEI Pharma, Inc.Collaborator:
Kyowa KirinTreatments:
Bendamustine Hydrochloride
Cyclophosphamide
Prednisone
Rituximab
Vincristine
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