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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
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
Time frame: From first dose to 3 years following first dose
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of all causality all grade adverse events
Time frame: From first dose to 100 days following last dose (up to approximately 23 months)
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.
Time frame: From first dose to 3 years or 5 years following first dose
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.
Time frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Percentage of Participants Negative for Minimal Residual Disease (MRD)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix, Arizona, United States
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
Antranik Agop Bedros
Loma Linda, California, United States
Miller Children's and Women Hospital
Long Beach, California, United States
Children'S Hospital Of L.A.
Los Angeles, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lpch & Sumc
Palo Alto, California, United States
...and 118 more locations
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%
Time frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
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.
Time frame: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)