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

Stopped early · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone B Cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), High Grade Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma (MCL)

In brief

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

Key facts

Study ID

NCT02914938

Run by

MEI Pharma, Inc.

People needed

97

Starts

2016-10-01

Expected to finish

2023-03-29

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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)

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Compassionate Care — Corona, California, United States
• Sylvester Comprehensive Cancer Center (Univ of Miami School of Med) — Miami, Florida, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana Farber — Boston, Massachusetts, United States
• Memorial Sloan Kettering — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering — Middletown, New Jersey, United States
• Memorial Sloan Kettering — Montvale, New Jersey, United States
• Memorial Sloan Kettering — Commack, New York, United States
• Memorial Sloan Kettering — Harrison, New York, United States
• NYU Langone Laura & Isaac - Perlmutter Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Stony Brook — Stony Brook, New York, United States
• Memorial Sloan Kettering — Uniondale, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Vanderbilt — Nashville, Tennessee, United States
• University of Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Swedish Cancer Institute — Edmonds, Washington, United States
• Swedish Cancer Institute — Issaquah, Washington, United States
• Swedish Cancer Center — Seattle, Washington, United States
• Carbone Cancer Center — Madison, Wisconsin, United States
• lstituto Oncologico della Svizzera ltaliana Ospedale Regionale Bellinzona e Valli CH — Bellinzona, Switzerland

Full record on ClinicalTrials.gov

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