Clinical Trials

Inclusion Criteria:

1. Common to All Indications:
   • Life expectancy at least 12 weeks
   • ECOG Performance Status of 0-2 
2. 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 
3. 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
4. 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:

1. 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
2. For AML Subjects:
   • Acute promyelocytic leukemia (M3)
   • Left ventricular ejection fraction < institutional limits of normal
3. 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)
4. 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