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Leukemia Clinical Trials

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MEI Pharma ME-401-002

A Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Jennifer Howgate-Klingaman, MSN, RN
    484-526-6038

    jennifer.howgate-klingaman@sluhn.org

     

     

  • Treatment Agent: ME-401

    Synopsis: The purpose of the study is to investigate an experimental drug called ME-401. ME-401 is being developed by MEI Pharma Inc. (the Sponsor of this study) as a potential treatment for different types of lymphoma and leukemia, which are forms of cancer that affect lymphocytes, immune cells present in the blood, lymph nodes, and other organs. ME-401 is an investigational drug because it is not yet approved by the United States Food and Drug Administration (FDA).

    This study has been designed to look at the safety of ME-401 (also known as the study drug), how your body tolerates the drug, how effective the drug may be and how the drug is taken up by your body when administered orally as a single dose.

      • 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
      • QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
      • For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0
    • 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