This trial is active, not recruiting.

Condition leukemia, pediatric
Treatment dasatinib
Phase phase 2
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Collaborator Children's Oncology Group
Start date January 2012
End date May 2017
Trial size 75 participants
Trial identifier NCT01460160, 2011-001123-20, AALL1122, CA180-372


The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
dasatinib Sprycel
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity

Primary Outcomes

Event free survival (EFS) rate at 3 years of Dasatinib plus chemotherapy compared with external historical controls
time frame: Three years following the 75th patient's first visit

Secondary Outcomes

Safety and feasibility of Dasatinib added to standard chemotherapy
time frame: Up to 2 years from first dose of Dasatinib
Event free survival rate at 3 and 5 years
time frame: 3 and 5 years following the 75th patient's first visit
Minimal Residual Disease levels
time frame: At approximately 2 weeks, 8 weeks, 20 weeks after starting Dasatinib and at progression (up to 5 years after last dose of Dasatinib)
Complete Remission Rates
time frame: At 8 weeks and between week 17 and 20 after starting Dasatinib
Oncogene fusion protein (BCR-ABL) mutation status
time frame: Baseline (Induction phase 1B) and time of disease progression or relapse (Approximately up to 5 years)

Eligibility Criteria

Male or female participants from 1 year up to 17 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL) - Age >1 year and < less than 18 years old - Induction chemotherapy ≤ 14 days according to institutional standard of care - Adequate liver, renal and cardiac function Exclusion Criteria: - Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor - Extramedullary involvement of the testicles - Active systemic bacterial, fungal or viral infection - Down syndrome

Additional Information

Official title A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.