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:	Active, not recruiting
Conditions:	Blood Cancer, Leukemia
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any - 18
Updated:	1/31/2018
Start Date:	February 19, 2009
End Date:	September 23, 2021

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

Cohort 2 was closed early to enrollment based on insufficient treatment response and poor
enrollment

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 found this trial at

sites

Children's Hospital of Philadelphia

South 34th Street
Philadelphia, Pennsylvania 19104

215-590-1000