Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT01460160
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
- Extramedullary involvement of the testicles
- Active systemic bacterial, fungal or viral infection
- Down syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Dasatinib Dasatinib -
- Primary Outcome Measures
Name Time Method 3-year Event-free Survival (EFS) Rate From first dose to 3 years following first dose 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
- Secondary Outcome Measures
Name Time Method Percentage of Participants Negative for Minimal Residual Disease (MRD) 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) 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%
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) From first dose to 3 years or 5 years following first dose 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.
Complete Remission Rate 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) 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.
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) 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.
Number of Participants Experiencing Adverse Events From first dose to 100 days following last dose (up to approximately 23 months) Number of participants experiencing different types of all causality all grade adverse events
Trial Locations
- Locations (94)
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
Scroll for more (84 remaining)University Of Alabama At Birmingham🇺🇸Birmingham, Alabama, United States