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

Completed · Phase 2

Conditions studied: Leukemia

In brief

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

Key facts

Study ID

NCT00777036

Run by

Bristol-Myers Squibb

People needed

133

Starts

2009-03-20

Expected to finish

2025-01-27

Last updated by the study team

2025-08-29

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
• Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
• Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
• Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
• Target Population for the PK substudy subjects must meet relevant inclusion criteria

You may not qualify if…

• 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
• Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
• Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy
• Other inclusion/exclusion criteria may apply

Where it is running

• Local Institution - 0005 — Phoenix, Arizona, United States
• Phoenix Children'S Hospital — Phoenix, Arizona, United States
• Jonathan Jaques Children'S Cancer Center — Long Beach, California, United States
• Jonathan Jaques Children'S Cancer Center — Long Beach, California, United States
• Local Institution - 0001 — Long Beach, California, United States
• Children'S Hospital Of Orange County — Orange, California, United States
• Local Institution - 0024 — Orange, California, United States
• Children'S Hospital — Aurora, Colorado, United States
• Local Institution - 0004 — Aurora, Colorado, United States
• Children's Healthcare Of Atlanta - Egleston — Atlanta, Georgia, United States
• Local Institution - 047 — Atlanta, Georgia, United States
• Children's Hospital of Chicago — Chicago, Illinois, United States
• Local Institution - 0072 — Chicago, Illinois, United States
• Local Institution — Chicago, Illinois, United States
• Dana Faber Cancer Institute — Boston, Massachusetts, United States
• Dana Farber Cancer Institute. — Boston, Massachusetts, United States
• Local Institution - 0040 — Boston, Massachusetts, United States
• Stephen D. Hassenfeld Children'S Center — New York, New York, United States
• Local Institution - 0061 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Oregon Health & Sci Univ — Portland, Oregon, United States
• Local Institution - 0002 — Portland, Oregon, United States
• Oregon Health & Sci Univ — Portland, Oregon, United States
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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