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Completed

NCT Number: NCT01460160

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

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

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Key information

Conditions

Leukemia, Pediatric Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Sth Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

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

Other names: Sprycel

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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%

  5. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Children's Oncology Group
  • EsPhALL

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2021
First posted
Oct 26, 2011
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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