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

• Status: Unknown status
• Trial end date: 2021-09-23
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

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