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
NCT ID: NCT01120457
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2010-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Dose Escalation and Expansion cohort (AML Patients)
Dose Escalation: BMS-936564 0.3-10 mg/kg solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle)
Dose Expansion: BMS-936564 maximum tolerated dose (MTD) based on dose escalation, solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle)
BMS-936564 (Anti-CXCR4)
Arm 2: Dose Expansion cohort (DLBCL Patient)
BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)
BMS-936564 (Anti-CXCR4)
Arm 3: Dose Expansion cohort (CLL Patient)
BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)
BMS-936564 (Anti-CXCR4)
Arm 4: Dose Expansion cohort (FL Patient)
BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle)
BMS-936564 (Anti-CXCR4)
Interventions
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BMS-936564 (Anti-CXCR4)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA212-001
Identifier Type: -
Identifier Source: org_study_id
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