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

  • STATUS
    Recruiting
  • End date
    Dec 16, 2025
  • participants needed
    180
  • sponsor
    MEI Pharma, Inc.
Updated on 16 April 2021
Investigator
MEI Pharma MEI Pharma
Primary Contact
Hospital Universitario Quiron Salud Madrid (3.7 mi away) Contact
+144 other location
ct scan
ejection fraction
follicular lymphoma
marginal zone lymphoma
refractory follicular lymphoma

Summary

This is the study of the PI3K 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

Description

This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3K 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.

Details
Condition Follicular Lymphoma, Lymphoma, MALT Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment ME-401, Zandelisib (ME-401)
Clinical Study IdentifierNCT03768505
SponsorMEI Pharma, Inc.
Last Modified on16 April 2021

Eligibility

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
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
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