Status:
TERMINATED
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Lead Sponsor:
MEI Pharma, Inc.
Collaborating Sponsors:
Kyowa Kirin, Inc.
Conditions:
Follicular Lymphoma (FL)
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 wi...
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...
Eligibility Criteria
Inclusion
- 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:
- FL Gr 1, Gr 2, or Gr 3a
- 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
- 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
Key Trial Info
Start Date :
August 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04745832
Start Date
August 13 2021
End Date
March 20 2023
Last Update
November 4 2024
Active Locations (141)
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1
The Oncology Institute of Hope and Innovation
Tucson, Arizona, United States, 85745
2
Orange Coast Memorial Medical Center
Fountain Valley, California, United States, 92708
3
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
4
The Oncology Institute of Hope and Innovation
Riverside, California, United States, 92506