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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 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.

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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

Conditions Studied

Chronic Lymphocytic Leukemia Follicular Lymphoma Acute Myelogenous Leukemia Diffuse Large B-Cell Leukemia

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

FieldValue
Enrollment Target 96 participants
Start Date 2010-08
Est. Completion 2014-11
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

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What the Registry Record Tells You About NCT01120457

The ClinicalTrials.gov registry entry for NCT01120457 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (47% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.