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NCT01120457 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Chronic Lymphocytic Leukemia and Follicular Lymphoma, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 11
- Study locations
NCT01120457: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Follicular Lymphoma, sponsored by Bristol-Myers Squibb.
NCT01120457 is a Phase 1 study of Chronic Lymphocytic Leukemia and Follicular Lymphoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 96 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (47% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01120457, a Phase 1 study of Chronic Lymphocytic Leukemia and Follicular Lymphoma, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 11
- Study locations
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
Primary Outcome
Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities
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 |
What the finished NCT01120457 record still lists
NCT01120457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (47% lower).
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.
NCT01120457 lists 11 locations in 9 states (California, Alabama, Florida).
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.
What interventions are being tested in trial NCT01120457?
The interventions under investigation include: BMS-936564 (Anti-CXCR4) (DRUG).
Who is sponsoring clinical trial NCT01120457?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01120457's enrollment target sits among peer trials
96 66th of 187 higher than 122 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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