Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Collaborators:
Children's Oncology Group
EsPhALL - European Intergroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukaemia with Imatinib
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01460160
First received: October 25, 2011
Last updated: June 12, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Leukemia, Pediatric
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Event free survival (EFS) rate at 3 years of Dasatinib plus chemotherapy compared with external historical controls [ Time Frame: Three years following the 75th patient's first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and feasibility of Dasatinib added to standard chemotherapy [ Time Frame: Up to 2 years from first dose of Dasatinib ] [ Designated as safety issue: Yes ]
    Based on adverse events and laboratory results

  • Event free survival rate at 3 and 5 years [ Time Frame: 3 and 5 years following the 75th patient's first visit ] [ Designated as safety issue: No ]
  • Minimal Residual Disease levels [ Time Frame: At approximately 2 weeks, 8 weeks, 20 weeks after starting Dasatinib and at progression (up to 5 years after last dose of Dasatinib) ] [ Designated as safety issue: No ]
  • Complete Remission Rates [ Time Frame: At 8 weeks and between week 17 and 20 after starting Dasatinib ] [ Designated as safety issue: No ]

    Complete remission will be defined as <5% lymphoblasts in bone marrow (ie M1 bone marrow) and Cerebrospinal Fluid (CSF) with no evidence of other extramedullary disease at end of induction compared with AIEOP BFM 2000 and the Amended EsPhALL trials

    AIEOP = Associazione Italiana di Ematologia Pediatrica

    BFM = Berlin-Frankfurt-Müenster Leukemia Backbone Therapy

    EsPhALL = European InterGroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukemia


  • Oncogene fusion protein (BCR-ABL) mutation status [ Time Frame: Baseline (Induction phase 1B) and time of disease progression or relapse (Approximately up to 5 years) ] [ Designated as safety issue: No ]
    BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain


Estimated Enrollment: 75
Study Start Date: January 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Dasatinib Drug: Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Name: Sprycel

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460160

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 127 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Children's Oncology Group
EsPhALL - European Intergroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukaemia with Imatinib
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01460160     History of Changes
Other Study ID Numbers: CA180-372, 2011-001123-20, AALL1122
Study First Received: October 25, 2011
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014