Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
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
  • Phase

    Phase 2
  • Study Type

  • Intervention/Treatment

    dasatinib ...
  • Study Participants

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
Study Started
Apr 13
Primary Completion
May 28
Study Completion
Jun 01
Results Posted
Aug 21
Last Update
Dec 08

Drug Dasatinib

Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity

  • Other names: Sprycel

Arm 1: Dasatinib Experimental


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


Dasatinib Cohort

All Events

Event Type Organ System Event Term Dasatinib Cohort

3-year Event-free Survival (EFS) Rate

3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: Lack of complete response in bone marrow Relapse at any site Development of second malignant neoplasm Death from any cause

Dasatinib Cohort

Percentage of Participants
90% Confidence Interval: 57.7 to 73.7

Number of Participants Experiencing Adverse Events

Number of participants experiencing different types of all causality all grade adverse events

Dasatinib Cohort

Adverse Events (AEs)

AEs leading to discontinuation


Drug-related AEs

Serious Adverse Events (SAEs)

Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)

Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.

Dasatinib Cohort

3-year EFS Estimate

Percentage of Participants
95% Confidence Interval: 55.5 to 73.7

5-year EFS Estimate

Percentage of Participants
95% Confidence Interval: 42.8 to 62.3

Complete Remission Rate

Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.

Dasatinib Cohort

End of Consolidation period

Percentage of Partcipants

End of Induction period Ia

Percentage of Partcipants

End of Induction period Ib

Percentage of Partcipants

Percentage of Participants Negative for Minimal Residual Disease (MRD)

MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%

Dasatinib Cohort

End of Consolidation period

Percentage of Participants
95% Confidence Interval: 62.12 to 80.02

End of Induction period Ia

Percentage of Participants
95% Confidence Interval: 19.98 to 37.88

End of Induction period Ib

Percentage of Participants
95% Confidence Interval: 42.89 to 62.6

Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse

A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.

Dasatinib Cohort

At Baseline

Percentage of participants

At Disease Progression or Relapse

Percentage of participants

Age, Continuous

Years (Mean)
Standard Deviation: 4.467

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Sex: Female, Male

Treatment Phase

Dasatinib Cohort

Follow-up Phase

Dasatinib Cohort