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Clinical Trials (PDQ®)

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed1 to 21Pharmaceutical / IndustryCA180-226
2008-002260-33, NCT00777036

Trial Description

Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Further Study Information

Cohort 2 is closed to enrollment

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • CP-CML who prove resistant or intolerant to imatinib (cohort #1)
  • Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (cohort #2)
  • Newly diagnosed, treatment naive CP-CML (cohort #3)
  • Lansky or Karnofsky scale >50
  • Life expectancy ≥12 weeks
  • Adequate hepatic and renal function
  • Written informed consent

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers SquibbStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00777036
ClinicalTrials.gov processed this data on December 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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