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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

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

Exclusion Criteria:

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