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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study

Outcome Description:

MCyR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-226

NCT ID:

NCT00777036

Start Date:

March 2009

Completion Date:

September 2016

Related Keywords:

• Leukemia
• Leukemia, Pediatric
• Leukemia
• Leukemia, Myeloid, Chronic-Phase