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NCT00103844 · ClinicalTrials.gov registry record · Phase 2

Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

A Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
150
Enrollment target
20
Study locations

NCT00103844 is a Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 150 participants, below the 206-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00103844, a Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Conditions Studied

Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia

Interventions

  • DRUG Dasatinib
  • DRUG Imatinib

Study Locations (20)

California

  • Local Institution - Anaheim
  • Local Institution - Bakersfield
  • Local Institution - Fullerton
  • Local Institution - Loma Linda
  • Local Institution - Los Angeles
  • Local Institution - Monterey Park
  • Local Institution - San Diego
  • Local Institution - Santa Barbara
  • Local Institution - Santa Maria
  • Local Institution - Stanford
  • Local Institution - Vallejo

Georgia

  • Local Institution - Athens
  • Local Institution - Atlanta
  • Local Institution - Lawrenceville

Florida

  • Local Institution - Jacksonville
  • Local Institution - Tampa

Alabama

  • Local Institution - Birmingham

Colorado

  • Local Institution - Aurora

Connecticut

  • Local Institution - Hartford

District of Columbia

  • Local Institution - Washington D.C.

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2005-02
Est. Completion 2008-03
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00103844

The ClinicalTrials.gov registry entry for NCT00103844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (27% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Dasatinib is the first listed.

NCT00103844 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Georgia, Florida.

Frequently Asked Questions

What is clinical trial NCT00103844 about?

NCT00103844 is a clinical study titled "Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia". The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

What is the current status of trial NCT00103844?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2005-02. Estimated completion is 2008-03.

What conditions does trial NCT00103844 study?

This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia.

What interventions are being tested in trial NCT00103844?

The interventions under investigation include: Dasatinib (DRUG), Imatinib (DRUG).

Who is sponsoring clinical trial NCT00103844?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00103844 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.