A Phase 1, Open-Label, Multicenter Study of BMS-936564 (MDX-1338) in Subjects with Relapsed/Refractory Acute Myelogenous Leukemia and Selected B-cell Malignancies
B Douglas Smith
This is a Phase 1 study to determine the maximum tolerated dose of MDX-1338 in patients with relapsed/refractory AML.
Diagnosis: Relapsed/refractory AML (APL excluded) unsuitable for standard therapy. If relapsed, no more than 2 relapses are allowed. If refractory, must be primary refractory to at least 1 induction regimen. ï¿½Must have ability and willingness to give informed consent. ï¿½Patients must, in the opinion of the investigator, be capable of complying with the protocol. ï¿½Life expectancy greater than 12 weeks ï¿½Age greater than 18 years of age ï¿½Must be in fair to good physical condition with good organ function. ï¿½Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study for at least 70 days (for women) and 180 days (for men) following the last dose of study drug ï¿½Women must not be pregnant or nursing ï¿½Must be at least 2 weeks since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy, except for hydroxyurea which can continue up to the day before start of study. ï¿½May not have had prior anti-CXCR4 therapy. ï¿½May not have had use of other investigational drugs within 2 weeks before start of study. ï¿½May not have had major surgery within 4 weeks before start of study. ï¿½May not have another cancer requiring cytotoxic therapy. ï¿½May not be HIV positive or may not have active autoimmune disease requiring immunosuppressive therapy. ï¿½May not have active infection with Hepatitis B, Hepatitis C, or tuberculosis. ï¿½May not have active GVHD or life threatening active bleeding. ï¿½May not have active infection requiring IV systemic therapy within 7 days before receiving the first dose of study drug. ï¿½May not have central nervous system leukemia. ï¿½May not have made donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks before start of study. ï¿½For patients who have had prior bone marrow transplant for AML, bone marrow transplant must have been greater than 3 months ago. ï¿½May not have current drug or alcohol abuse. ï¿½Must have ability to be venipunctured and/or tolerate venous access. ï¿½May not have history of hypersensitivity or allergy to monoclonal antibodies or related compounds. May not have a history of significant drug allergy (i.e. anaphylaxis or liver failure).
Patients will receive an IV infusion of MDX-1338 on Day 1 of Cycle 1. Cycle 1 is a 7 day cycle. Cycles 2 and beyond are 28 day cycles. For Cycles 2 and beyond, patients will receive IV infusions of MDX-1338 on Days 1, 8, and 15 with chemotherapy (Mitoxantrone + Etoposide + Cytarabine) given on Days 1 through 5. Testing during treatment will include periodic bone marrows, blood tests, and physical exams.
12/17/2013 04:02 AM