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

  • End date
    Apr 13, 2025
  • participants needed
  • sponsor
    MEI Pharma, Inc.
Updated on 4 October 2022
ct scan
ejection fraction
follicular lymphoma
marginal zone lymphoma
refractory follicular lymphoma


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


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 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 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.

Condition Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma
Treatment ME-401, Zandelisib (ME-401)
Clinical Study IdentifierNCT03768505
SponsorMEI Pharma, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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
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
Age ≥ 18
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
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