NCT01120457 - 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 | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

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

...and 1 more locations

Outcomes

Primary Outcomes

Safety and tolerability as monotherapy

Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities

Time frame: Within the first 7 days for AML

Safety and tolerability as monotherapy

Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities

Time frame: Within 28 days for the selected B-cell malignancies

Secondary Outcomes

Safety, as measured by vital signs, clinical laboratory tests,ECOG performance status, physical exams, 12 lead ECGs incidence and severity of adverse events

ECOG - Eastern Cooperative Oncology Group ECG - Electrocardiograms