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

  • Percentage of Participants With 3-year Event-free Survival (EFS)
    • Time Frame: 3 years
    • EFS is defined as the time from the starting date of dasatinib until an event. In the primary analysis, the 3-year EFS response rate is defined as the number of participants without event after 3 years since the start of dasatinib divided by the number of treated participants and expressed as a percentage. 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

  • Percentage of Participants With 3-year EFS Rate (K-M Estimate)
    • Time Frame: 3 years
    • Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-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.
  • Overall Survival (K-M Estimate) Rate at 3 Years
    • Time Frame: 3 years
    • Overall survival is defined as time from the first day of dasatinib treatment until the time of death. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The rate of OS at 3 years was expressed as a percentage of all treated participants.
  • Complete Remission Rate
    • Time Frame: 3 years
    • CR rate is defined as the proportion of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease, and expressed as a percentage. 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 Minimal Residual Disease Based on Ig/TCR Method
    • Time Frame: 3 years
    • The number of participants with MRD at the end of the Induction 1B and Consolidation periods was divided by the number of treated participants and expressed as a percentage.
  • Number of Participants With AEs or Drug Related Death
    • Time Frame: Approximately 3 years
    • The number of participants with any AE or with study drug-related death was reported for each arm.
  • Number of Participants With BCR-ABL Mutations at Time of Disease Progression
    • Time Frame: Approximately 3 years
    • The number of Ph+ ALL participants with BCR-ABL Mutations at Disease Progression or Relapse was reported for each arm.
  • Number of Participants With Grade 3-4 Hematology Laboratory Abnormalities.
    • Time Frame: Approximately 3 years
    • The number of participants experiencing Grade 3 or 4 hematology laboratory abnormalities was reported by arm.
  • Number of Participants With Grade 3-4 Liver Function Laboratory Abnormalities.
    • Time Frame: Approximately 3 years
    • The number of participants experiencing Grade 3 or 4 liver function laboratory abnormalities was reported by arm.
  • Number of Participants With Grade 3-4 Kidney Function Abnormalities
    • Time Frame: Approximately 3 years
    • The number of participants experiencing Grade 3 or 4 kidney function laboratory abnormalities was reported by arm.
  • Number of Participants With Grade 3-4 Serum Chemistry Abnormalities
    • Time Frame: Approximately 3 years
    • The number of participants with grade 3-4 serum chemistry laboratory abnormalities was presented for each arm.

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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