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

ME-401-004

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.

2021-08-13

2023-03-20

2023-03-20

Terminated

Early phase I

82

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1: Rituximab plus Zandelisib\n\nArm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 82, 'type': 'ACTUAL'}}

2023-12-13