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Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01460160
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : August 21, 2018
Last Update Posted : December 8, 2021
Sponsor:
Collaborators:
Children's Oncology Group
EsPhALL
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Leukemia, Pediatric Drug: Dasatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 13, 2012
Actual Primary Completion Date : May 28, 2017
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dasatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Dasatinib Drug: Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Name: Sprycel


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460160


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Children's Oncology Group
EsPhALL
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 28, 2013
Statistical Analysis Plan  [PDF] October 28, 2013

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01460160    
Other Study ID Numbers: CA180-372
2011-001123-20 ( EudraCT Number )
AALL1122 ( Other Identifier: COG )
First Posted: October 26, 2011    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: December 8, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Dasatinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents