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

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.