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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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
Phase II
Mol. targeted/Immunotherapy/Biologics
Dholaria, Bhagirathbhai
Vanderbilt University


18 Years
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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