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


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateNovember 2014   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 21, 2008)		Rates of major cytogenetic response and complete hematologic response [ Time Frame: every 3,6 and 12 months during the first year. Every 6 months during the second year. Yearly thereafter and at the end of protocol therapy ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00777036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 21, 2008)
  • Best cytogenetic responses, major and complete molecular response duration of and time to cytogenetic and hematologic response [ Time Frame: every 3, 6 and 12 months during the first year. Every 6 months during the second year. Yearly thereafter, and at the end of protocol therapy ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Phase II Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
Official Title  ICMJEA Phase II Study of Dasatinib Therapy in Children and Adolescents With Ph+ Leukemia With Resistance or Intolerance to Imatinib
Brief Summary

The purpose of this study is to find out if dasatinib is effective in children and adolescents with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) who prove resistant or intolerant to imatinib or relapsed after imatinib. The side effects this oral investigational drug may have in children and adolescents will also be studied

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Condition  ICMJELeukemia
Intervention  ICMJE
  • Drug: Dasatinib
    Tablets / Oral Suspension, Oral, Dose escalation allowed, 60 mg/m2 QD with a maximum dose of 100 mg QD {max dose of 120 mg QD if BSA >1.7m2}, once daily, minimum of 24 months, may continue as long as deriving clinical benefit
    Other Names:
    • Sprycel
    • BMS-354825
  • Drug: Dasatinib
    Tablets / Oral Suspension, Oral, Dose escalation allowed, 80 mg/m2 QD with a maximum dose of 140 mg QD {max dose of 170 mg QD if BSA >1.7m2}, once daily, minimum of 24 months, may continue as long as deriving clinical benefit
    Other Names:
    • Sprycel
    • BMS-354825
Study Arms / Comparison Groups
  • Cohort 1: CP-CML: Experimental
    Intervention: Drug: Dasatinib
  • Cohort 2: Ph+ ALL or AP- or BP-CML: Experimental
    Intervention: Drug: Dasatinib

Recruitment Information

Estimated Enrollment  ICMJE59
Estimated Completion DateNovember 2014
Estimated Primary Completion DateNovember 2014   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ph+ CML in chronic, accelerated or blast phase or Ph+ ALL with imatinib-resistant disease or intolerance
  • Lansky or Karnofsky scale > 50
  • Life expectancy >= 12 weeks
  • Adequate hepatic renal function

Exclusion Criteria:

  • Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
  • Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
  • Isolated extramedullary disease
  • Prior therapy with dasatinib
GenderBoth
Ages1 Year to 20 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Brazil,   France,   Italy,   Netherlands,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00777036
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA180-226, EUDRACT: 2008-002260-33
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb