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

Trial Status: Active

This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed / refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy

Inclusion Criteria

  • Histologically confirmed diagnosis of follicular lymphoma (FL) as defined in the World Health Organization (WHO) classification scheme, limited to Grade 1, 2, or 3a
  • Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL
  • 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 Criteria

  • 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

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 120 subjects will be enrolled and treated with ME-401 on the intermittent schedule.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
MEI Pharma Inc

  • Primary ID ME-401-003
  • Secondary IDs NCI-2019-00564, 2018-002896-17
  • Clinicaltrials.gov ID NCT03768505