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Active, Not Recruiting

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia - CA180-018

Updated: 20 September, 2017   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: Stratum 1 (Ph+ CP-CML)
Drug: Dasatinib
Experimental: Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Drug: Dasatinib
Experimental: Stratum 4 (Ph- ALL/AML)
Drug: Dasatinib

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or intolerance to imatinib. - Ph-negative acute leukemia in second or subsequent relapse - Age >1 and <21 years - Lansky or Karnofsky scale >60 - Life expectancy >3 weeks - Adequate hepatic and renal function - Written informed consent Exclusion Criteria: - Subjects for whom potentially-curative therapy was available, including electing immediate [ie, planned <45 days] stem-cell transplantation. Subjects in Stratum 1 were to have had an ongoing identical HLA donor search, and may have discontinued study if a donor became available.) - Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due to their CNS disease). - Subjects who had not recovered from acute toxicity of previous therapy. - Clinically-significant disorder of platelet function (eg, von Willebrand's disease) or ongoing gastrointestinal bleeding. - Serious uncontrolled medical disorder or active infection - Uncontrolled or significant cardiovascular disease - Use of any investigational agent or any other anticancer agent within 14 days prior to treatment start. - Prior therapy with dasatinib - Subjects taking medications that irreversibly inhibit platelet function or anticoagulants. - Subjects taking certain medications that are accepted to have a risk of causing QTc prolongation. - Women of Child Bearing Potential with a positive pregnancy test prior to study drug administration. - Expected noncompliance, or unable to have regular follow-up due to psychologic, social, familial, or geographic reasons. - Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study.

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com