We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01460160
Recruitment Status : Active, not recruiting
First Posted : October 26, 2011
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
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 : January 30, 2012
Primary Completion Date : May 28, 2017
Estimated Study Completion Date : May 28, 2021

Arms and Interventions

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety and feasibility of Dasatinib added to standard chemotherapy [ Time Frame: Up to 2 years from first dose of Dasatinib ]
    Based on adverse events and laboratory results

  2. Event free survival rate at 3 and 5 years [ Time Frame: 3 and 5 years following the 75th patient's first visit ]
  3. 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) ]
  4. Complete Remission Rates [ Time Frame: At 8 weeks and between week 17 and 20 after starting Dasatinib ]

    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

  5. 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) ]
    BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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

  Show 128 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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01460160     History of Changes
Other Study ID Numbers: CA180-372
2011-001123-20 ( EudraCT Number )
AALL1122 ( Other Identifier: COG )
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action