Non Hodgkin Lymphoma Clinical Trial

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

Summary

A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

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Full Description

This is a three-arm study of ME-401 alone, of ME-401 in combination with rituximab, and of ME-401 in combination with zanubrutinib in subjects with relapsed/refractory CLL/SLL or B cell NHL. The 3 arms of the study will be conducted in parallel, with subject allocation to ME-401 alone, ME-401 plus rituximab, or ME-401 plus zanubrutinib based on disease type and availability of an open enrollment slot.

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Eligibility 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 or subject had disease progression
Subjects with CLL/SLL must have prior treatment with BTK inhibitor and must have had progression or recurrence while on treatment of within 12 mos from BTK treatment
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:
No prior therapy with PI3Kδ inhibitors
No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression
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

Inclusion Criteria ME-401 in Combination with Zanubrutinib

Diagnosis of relapsed/refractory CLL or histologically-confirmed relapsed/refractory SLL or FL, MZL, MCL, DLBCL NOS (germinal center B-cell type or activated B-cell type)
No prior therapy with PI3Kδ inhibitors
No prior therapy with BTK inhibitors
Subjects with CLL, SLL, FL, MCL, and MZL must have a failure of at least 1 prior systemic therapy, require treatment in the opinion of the investigator, and be considered by the investigator a candidate for therapy subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies
For subjects with SLL, FL, MZL, MCL, DLBCL: At least one bi dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by CT scan or MRI
QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec)
Left ventricular ejection fraction > 50% as measured by echocardiogram or multigated acquisition (MUGA) scan
Willingness to participate in collection of pharmacokinetic samples
For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0

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
History of severe bleeding disorders (ME-401 plus zanubrutinib arm only)
Known central nervous system (CNS) hemorrhage or stroke within 6 months prior to start of study drugs (ME-401 plus zanubrutinib arm only)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

177

Study ID:

NCT02914938

Recruitment Status:

Active, not recruiting

Sponsor:

MEI Pharma, Inc.

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There are 23 Locations for this study

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University of Arizona
Tucson Arizona, 85724, United States
Compassionate Care
Corona California, 92708, United States
Sylvester Comprehensive Cancer Center (Univ of Miami School of Med)
Miami Florida, 33136, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana Farber
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering
Commack New York, 11725, United States
Memorial Sloan Kettering
Harrison New York, 10604, United States
NYU Langone Laura & Isaac - Perlmutter Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Stony Brook
Stony Brook New York, 11794, United States
Memorial Sloan Kettering
Uniondale New York, 11553, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Vanderbilt
Nashville Tennessee, 37240, United States
University of Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Swedish Cancer Institute
Edmonds Washington, 98026, United States
Swedish Cancer Institute
Issaquah Washington, 98029, United States
Swedish Cancer Center
Seattle Washington, 98104, United States
Carbone Cancer Center
Madison Wisconsin, 53792, United States
lstituto Oncologico della Svizzera ltaliana Ospedale Regionale Bellinzona e Valli CH
Bellinzona , , Switzerland

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

177

Study ID:

NCT02914938

Recruitment Status:

Active, not recruiting

Sponsor:


MEI Pharma, Inc.

How clear is this clinincal trial information?

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