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Protocol No. UW16061

Principal Investigator Kenkre, Vaishalee

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Three-Arm Study of ME-401 Monotherapy in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL), of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell Non-Hodgkin s Lymphoma (NHL), and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Objective The purpose of the study is to investigate an investigational 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 and after multiple doses over the course of the study.

Treatment ME-401 blocks a molecule called PI3K delta, which is typically present in normal lymphocytes and lymphoma cells. ME-401 was shown to suppress lymphoma growth in several laboratory studies. There is limited information on ME-401 use in humans. ME-401 has been studied in healthy volunteers where it was given at different doses for only one day. This is the first study where ME-401 will be taken by patients over extended periods of time.

Description If you are enrolled, you will be assigned to one of the seven planned dose levels. Prior to patients being enrolled into the next cohort the study doctor and other study personnel will assess the safety of the study drug in the current and prior cohorts. ME-401, the study drug, will be provided as capsules to be taken once daily on an empty stomach. Throughout the study treatment period, regardless of which cohort you are assigned to, you will be monitored to see if your disease has worsened and if you are having any side effects. If your treatment appears to be safe for you, you may continue with treatment if the study doctor feels it is in your best interest and the study is still ongoing. If you develop side effects to the study medication, your doctor may decrease the dose or hold off study medication until you recover from these side effects.

Key Eligibility
  • Diagnosis of relapsed/refractory CLL or histologically-confirmed relapsed/refractory SLL or FL, mantle cell lymphoma, marginal zone lymphoma, DLBCL, high grade B cell lymphoma
  • Must require treatment in the opinion of the investigator
  • No prior therapy with PI3Kδ inhibitors
  • No prior therapy with BTK inhibitors unless the subject was intolerant of BTK therapy
  • Patients with known active histological transformation from CLL to an aggressive lymphoma are ineligible
  • Patients who are positive for Hep C or HIV are ineligible
  • Patients who have tested positive for hepatitis B surface antigen are ineligible
  • Patients who have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia are ineligible
  • Women who are breastfeeding are ineligible

Applicable Disease Sites Leukemia; Lymphoma

Therapies Involved Cytotoxic Chemotherapy; Immunotherapy

Drugs Involved BGB-3111 (Zanubrutinib); ME-401; Zanubrutinib; chimeric anti-CD20 monoclonal antibody (rituximab); idec-c2B8 (rituximab); rituxan (rituximab); rituximab

Status Open

Participating Institutions UW Hospital and Clinics