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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
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Colorado
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Connecticut
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Delaware
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United States of America
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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 Jersey
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New Mexico
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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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Rhode Island
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Tennessee
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Washington
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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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Quebec
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Canada
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Saskatchewan
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Italy
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Bologna
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Italy
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Cagliari
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Italy
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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 London
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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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Merseyside
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North Yorkshire
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Nottinghamshire
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Oxfordshire
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South Yorkshire
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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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01460160
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01460160