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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
Results First Posted : August 21, 2018
Last Update Posted : July 8, 2020
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 : 109 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 : January 30, 2012
Actual Primary Completion Date : May 28, 2017
Estimated Study Completion Date : May 28, 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. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


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:

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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: July 8, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action