Status:
COMPLETED
Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Innovative Therapies For Children with Cancer Consortium
Conditions:
Leukemia
Eligibility:
All Genders
12-20 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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.
Key Trial Info
Start Date :
March 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00306202
Start Date
March 31 2006
End Date
May 22 2019
Last Update
February 26 2021
Active Locations (13)
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1
Local Institution
Vienna, Austria, 1090
2
Local Institution
Nantes, France, 44093
3
Local Institution
Paris, France, 75475
4
Local Institution
Paris, France, 75571