CClinicalTrials.gg
CompletedNCT00103701Updated Apr 14, 2011

BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

A Phase 1 interventional study of Dasatinib in Leukemia, Myeloid, Chronic-phase and Leukemia, Lymphoblastic, Acute, Philadelphia-positive, sponsored by Bristol-Myers Squibb. Completed at 2 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2011-04-14.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Non-randomized
Ages
14 Years and older
Sex
All
01

Study summary

The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).

02

Conditions studied

  • Leukemia, Myeloid, Chronic-phase
  • Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Keywords

  • Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase
  • Philadelphia chromosome positive acute (Ph+ALL)
03

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
  • Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
  • Men and women, 14 years of age or older.
  • Adequate renal function.
  • Adequate hepatic function.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion criteria

Exclusion Criteria:

  • Patients who are eligible and willing to undergo transplantation during the screening period.
  • Women who are pregnant or breastfeeding.
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
  • Uncontrolled or significant cardiovascular disease.
  • Medications that increase bleeding risk.
  • Medications that change heart rhythms.
  • Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
  • History of significant bleeding disorder or unrelated to CML.
  • Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Study arms

  • Experimental
    1

    Drug: Dasatinib

Interventions

  • DrugDasatinib

    Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.

    Also known as: Sprycel

06

What researchers measure

Primary outcomes

  1. Establishment of MTD and recommended Phase II dose.

Secondary outcomes

  1. 1) Hematologic Response 2) Cytogenetic Response.

07

Study locations

2 sites
  • Local Institution
    Los Angeles, California, United States
  • Local Institution
    Houston, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00103701
Lead sponsor
Bristol-Myers Squibb
First posted
Feb 15, 2005
Start date
Nov 2003
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Apr 14, 2011

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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