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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

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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
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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