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A Study of ME-401 in Subjects With CLL / SLL, FL, and B-cell Non-Hodgkin's Lymphoma

This is a two-arm, Phase 1b, open-label, dose escalation study of ME-401 alone and an open-label study of ME-401 in combination with rituximab in patients with relapsed / refractory B-cell malignancies.
Leukemia, Lymphoma
Phase I
Adults
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
ME-401, Rituximab (Rituxan)
Reddy, Nishitha
National
Vanderbilt University
11-27-2017
Treatment
VICCHEM1714
NCT02914938

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Inclusion Criteria MEI-401 Alone: - Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL - No prior therapy with PI3Kd inhibitors - No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy - Subject must have failed at least 1 prior systemic therapy - QT-interval corrected according to Fridericia's formula (QTcF) ? 450 milliseconds (ms) - Left ventricular ejection fraction >50% - For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion >1.5 cm, as defined by Lugano Classification - Willingness to participate in collection of pharmacokinetic samples - A negative serum pregnancy test within 14 days of study Day 0, for females of childbearing potential Inclusion Criteria ME-401 in Combination with Rituximab - Diagnosis of relapsed/refractory CLL SLL or FL, MZL, DLBCL and high-grade B-cell lymphoma. Subjects must meet the following criteria for relapsed or refractory disease: 1. Relapsed disease: a subject who previously achieved a CR or PR, but demonstrated disease progression after a response duration of >6 months 2. Refractory disease: a subject who demonstrated disease progression within 6 months of most recent therapy - No prior therapy with PI3K? inhibitors - No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy - Subjects with CLL, SLL, FL, and MZL must have a failure of at least 1 prior systemic therapy and be considered by the investigator a candidate for therapy with a rituximab-based regimen; subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies. - QT-interval corrected according to Fridericia's formula (QTcF) ?450 milliseconds (ms) - Left ventricular ejection fraction >50% - For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion >1.5 cm, as defined by Lugano Classification - Willingness to participate in collection of pharmacokinetic samples - A negative serum pregnancy test within 14 days of study Day 0 for females of childbearing potential Exclusion Criteria: - Known histological transformation from CLL to an aggressive lymphoma - Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia - Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody - Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody - Ongoing drug-induced pneumonitis - History of clinically significant cardiovascular abnormalities

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