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Tyrosine Kinase Inhibitor

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

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Myeloid Leukemia
  • Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Secondary study objectives
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
CHR After Crossover
+10 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Active Comparator
Group II: 1Experimental Treatment1 Intervention
Active Comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
FDA approved
Dasatinib
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,694 Previous Clinical Trials
4,097,953 Total Patients Enrolled
~7 spots leftby Dec 2025
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