Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

Stopped early · Phase 2

Conditions studied: Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma

In brief

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 therapy

Key facts

Study ID

NCT03768505

Run by

MEI Pharma, Inc.

People needed

169

Starts

2019-06-25

Expected to finish

2023-03-24

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Tower Hematology Oncology — Beverly Hills, California, United States
• The Oncology Institute of Hope and Innovation — Downey, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• H. Lee Moffit Cancer Center — Tampa, Florida, United States
• Cleveland Clinic-Florida — Weston, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Advocate Health & Hospitals Corporation — Niles, Illinois, United States
• Investigative Clinical Research of Indiana LLC — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Medical School — Ann Arbor, Michigan, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• The Oncology Institute of Hope and Innovation — Henderson, Nevada, United States
• Memorial Sloan Kettering — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering — Middletown, New Jersey, United States
• Memorial Sloan Kettering — Montvale, New Jersey, United States
• San Juan Oncology — Farmington, New Mexico, United States
• Memorial Sloan Kettering — Commack, New York, United States
• Memorial Sloan Kettering — Harrison, New York, United States
• Clinical Research Alliance — Lake Success, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Memorial Sloan Kettering — Uniondale, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Oncology Institute of Hope and Innovation — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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