First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Diffuse Large B-Cell Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma

In brief

The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338) in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML

Key facts

Study ID

NCT01120457

Run by

Bristol-Myers Squibb

People needed

96

Starts

2010-08-01

Expected to finish

2014-11-01

Last updated by the study team

2015-03-06

Who can join

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

You may qualify if…

• A. Common to All Indications:
• Life expectancy at least 12 weeks
• ECOG Performance Status of 0-2
• B. For Acute myelogenous leukemia (AML) Subjects:
• First Relapse and primary induction failure in AML (M3 excluded)
• Secondary AML subjects from myelodysplastic syndrome (MDS) or prior chemotherapy are eligible. MDS-only subjects are not eligible
• C. For Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) Subjects:
• Must be at least 4 weeks (for FL) or 2 weeks (for DLBCL) since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy
• Ability to undergo tumor biopsy pre-treatment and at end of monotherapy period (though not mandatory for all subjects)
• Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
• D. For Chronic lymphocytic leukemia (CLL) Subjects:
• Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
• Must be at least 4 weeks since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy, including corticosteroids

You may not qualify if…

• A. Common to All indications:
• Prior anti-CXCR4 therapy including BMS-936564 (MDX-1338)
• Less than 3 months from prior hematopoietic stem cell transplant
• Presence of active graft versus host disease
• B. For AML Subjects:
• Acute promyelocytic leukemia (M3)
• Left ventricular ejection fraction < institutional limits of normal
• C. For FL, DLBCL Subjects:
• (For DLBCL): Inadequate renal function defined as creatinine clearance (by Cockcroft-Gault formula) < 60 mL/min
• Major surgery, not related to debulking procedures, within 21 days of first dose
• Myocardial infarction within 6 months prior to screening or Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
• Myelodysplastic syndrome (MDS)
• D. For CLL Subjects:
• No progression to more aggressive B-cell cancers, such as Richter's syndrome
• Major surgery within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator
• Myocardial infarction within 6 months prior to screening Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

Where it is running

• Uab Comprehensive Cancer Center — Birmingham, Alabama, United States
• Uc San Diego Moores Cancer Center — La Jolla, California, United States
• Usc - Norris Comprehensive Cancer Center And Hospital — Los Angeles, California, United States
• Ucla-Division Of Hematology/Oncology — Los Angeles, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• University Of Kansas Cancer Center And Medical Pavillion — Westwood, Kansas, United States
• B. Douglas Smith, M.D. — Baltimore, Maryland, United States
• Dana-Farber Cancer Inst — Boston, Massachusetts, United States
• The University Of Texas Md Anderson Cancer Center — Houston, Texas, United States
• University Of Washington School Of Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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