Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 28, 2017

Interventions

  • Drug: Dasatinib
    • Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity

Arms, Groups and Cohorts

  • Experimental: Arm 1: Dasatinib

Clinical Trial Outcome Measures

Primary Measures

  • 3-year Event-free Survival (EFS) Rate
    • Time Frame: 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 Measures

  • Number of Participants Experiencing Adverse Events
    • Time Frame: 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
  • Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
    • Time Frame: 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
    • 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)
    • 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 Negative for Minimal Residual Disease (MRD)
    • 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)
    • 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%
  • Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Collaborator
    • Children’s Oncology Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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