Status:
TERMINATED
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Lead Sponsor:
MEI Pharma, Inc.
Conditions:
Follicular Lymphoma (FL)
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic ther...
Detailed Description
This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme
- Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
- Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
- Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
- Age ≥ 18
- At least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
- Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
- QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
- Left ventricular ejection fraction (LVEF) ≥ 45%
Exclusion
- Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
- Known lymphomatous involvement of the central nervous system
- Uncontrolled clinically significant illness
- Ongoing or history of drug-induced pneumonitis
- History of clinically significant cardiovascular abnormalities
- History of clinically significant GI conditions
- Known history of, or active HIV infection
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT03768505
Start Date
June 25 2019
End Date
March 24 2023
Last Update
December 31 2024
Active Locations (115)
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1
Oncology Institute of Hope and Innovation
Tucson, Arizona, United States, 85710
2
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
3
Tower Hematology Oncology
Beverly Hills, California, United States, 90211
4
The Oncology Institute of Hope and Innovation
Downey, California, United States, 90241