Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005
- 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
- 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
- Subjects taking certain medications that are accepted to have a risk of causing QTc
- Women of Child Bearing Potential with a positive pregnancy test prior to study drug
- 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