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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
NCT01120457 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG BMS-936564 (Anti-CXCR4)
Study Locations (11)
California
- Uc San Diego Moores Cancer Center — La Jolla
- Usc - Norris Comprehensive Cancer Center And Hospital — Los Angeles
- Ucla-Division Of Hematology/Oncology — Los Angeles
Alabama
- Uab Comprehensive Cancer Center — Birmingham
Florida
- Mayo Clinic — Jacksonville
Illinois
- Northwestern University Feinberg School Of Medicine — Chicago
Kansas
- University Of Kansas Cancer Center And Medical Pavillion — Westwood
Maryland
- B. Douglas Smith, M.D. — Baltimore
Massachusetts
- Dana-Farber Cancer Inst — Boston
Texas
- The University Of Texas Md Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01120457
The ClinicalTrials.gov registry entry for NCT01120457 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which BMS-936564 (Anti-CXCR4) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01120457 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01120457 about?
NCT01120457 is a clinical study titled "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". 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
What is the current status of trial NCT01120457?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2010-08. Estimated completion is 2014-11.
What conditions does trial NCT01120457 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Follicular Lymphoma, Acute Myelogenous Leukemia, Diffuse Large B-Cell Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01120457?
The interventions under investigation include: BMS-936564 (Anti-CXCR4) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01120457?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01120457 being conducted?
This trial has 11 study locations across Alabama, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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