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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
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
Secondary ID [1] 0 0
2011-001123-20
Secondary ID [2] 0 0
CA180-372
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Pediatric 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
3-year Event-free Survival (EFS) Rate
Timepoint [1] 0 0
From first dose to 3 years following first dose
Secondary outcome [1] 0 0
Number of Participants Experiencing Adverse Events
Timepoint [1] 0 0
From first dose to 100 days following last dose (up to approximately 23 months)
Secondary outcome [2] 0 0
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
Timepoint [2] 0 0
From first dose to 3 years or 5 years following first dose
Secondary outcome [3] 0 0
Complete Remission Rate
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Percentage of Participants Negative for Minimal Residual Disease (MRD)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
Timepoint [5] 0 0
At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)

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
Minimum age
1 Year
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2021
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Sth Brisbane
Recruitment hospital [2] 0 0
Local Institution - Parkville
Recruitment hospital [3] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - Sth Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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Arkansas
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California
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Wisconsin
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Canada
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Bologna
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Cagliari
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Catania
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Italy
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Firenze
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Italy
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Genova
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Italy
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Monza
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Roma
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Italy
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Torino
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Italy
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Trieste
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Puerto Rico
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San Juan
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Avon
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Glamorgan
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Grampian
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Greater Manchester
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Hampshire
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Lanarkshire
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Lothian
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Surrey
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Tyne And Wear
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West Midlands
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United Kingdom
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Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
EsPhALL
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01460160