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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01460160
Registration number
NCT01460160
Ethics application status
Date submitted
25/10/2011
Date registered
26/10/2011
Date last updated
8/12/2021
Titles & IDs
Public title
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
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Scientific 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
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Secondary ID [1]
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2011-001123-20
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Secondary ID [2]
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CA180-372
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Pediatric
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Experimental: Arm 1: Dasatinib -
Treatment: Drugs: Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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3-year Event-free Survival (EFS) Rate
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Assessment method [1]
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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
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Timepoint [1]
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From first dose to 3 years following first dose
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Secondary outcome [1]
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Number of Participants Experiencing Adverse Events
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Assessment method [1]
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Number of participants experiencing different types of all causality all grade adverse events
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Timepoint [1]
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From first dose to 100 days following last dose (up to approximately 23 months)
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Secondary outcome [2]
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Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose to 3 years or 5 years following first dose
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Secondary outcome [3]
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Complete Remission Rate
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Secondary outcome [4]
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Percentage of Participants Negative for Minimal Residual Disease (MRD)
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Assessment method [4]
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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%
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Timepoint [4]
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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)
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Secondary outcome [5]
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Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
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Assessment method [5]
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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.
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Timepoint [5]
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At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
* 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
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Minimum age
1
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/04/2012
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2021
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - Sth Brisbane
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Local Institution - Parkville
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Local Institution - Nedlands
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4101 - Sth Brisbane
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Children's Oncology Group
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EsPhALL
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT01460160
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Trial related presentations / publications
Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/60/NCT01460160/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/60/NCT01460160/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01460160
Download to PDF