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Trial record 1 of 1 for:    NCT01460160
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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 : June 23, 2020
Sponsor:
Collaborators:
Children's Oncology Group
EsPhALL
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE October 26, 2011
Results First Submitted Date  ICMJE May 25, 2018
Results First Posted Date  ICMJE August 21, 2018
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE January 30, 2012
Actual Primary Completion Date May 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
  • 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
  • Event free survival rate at 3 and 5 years [ Time Frame: 3 and 5 years following the 75th patient's first visit ]
  • 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) ]
  • Complete Remission Rates [ Time Frame: At 8 weeks and between week 17 and 20 after starting Dasatinib ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Pediatric
Intervention  ICMJE Drug: Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Name: Sprycel
Study Arms  ICMJE Experimental: Arm 1: Dasatinib
Intervention: Drug: Dasatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 12, 2017)
109
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2011)
75
Estimated Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date May 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Italy,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460160
Other Study ID Numbers  ICMJE CA180-372
2011-001123-20 ( EudraCT Number )
AALL1122 ( Other Identifier: COG )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Children's Oncology Group
  • EsPhALL
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP