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Active, Not Recruiting

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 - CA180-226

Updated: 4 January, 2018   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 0-18

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort 1: Imatinib-resistant/intolerant CP-CML
Drug: Dasatinib
Experimental: Cohort 2: Ph+ALL or AP- or BP-CML
Drug: Dasatinib
Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML

Key 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Email Us

Have questions?
Email Us