Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01460160




Trial ID
NCT01460160
Ethics application status
Date submitted
25/10/2011
Date registered
25/10/2011
Date last updated
23/04/2018

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
Event free survival (EFS) rate at 3 years of Dasatinib plus chemotherapy compared with external historical controls
Timepoint [1] 0 0
Three years following the 75th patient's first visit
Secondary outcome [1] 0 0
Safety and feasibility of Dasatinib added to standard chemotherapy - Based on adverse events and laboratory results
Timepoint [1] 0 0
Up to 2 years from first dose of Dasatinib
Secondary outcome [2] 0 0
Event free survival rate at 3 and 5 years
Timepoint [2] 0 0
3 and 5 years following the 75th patient's first visit
Secondary outcome [3] 0 0
Minimal Residual Disease levels
Timepoint [3] 0 0
At approximately 2 weeks, 8 weeks, 20 weeks after starting Dasatinib and at progression (up to 5 years after last dose of Dasatinib)
Secondary outcome [4] 0 0
Complete Remission Rates - Complete remission will be defined as <5% lymphoblasts in bone marrow (ie M1 bone marrow) and Cerebrospinal Fluid (CSF) with no evidence of other extramedullary disease at end of induction compared with AIEOP BFM 2000 and the Amended EsPhALL trials
AIEOP = Associazione Italiana di Ematologia Pediatrica
BFM = Berlin-Frankfurt-Müenster Leukemia Backbone Therapy
EsPhALL = European InterGroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukemia
Timepoint [4] 0 0
At 8 weeks and between week 17 and 20 after starting Dasatinib
Secondary outcome [5] 0 0
Oncogene fusion protein (BCR-ABL) mutation status - BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain
Timepoint [5] 0 0
Baseline (Induction phase 1B) and time of disease progression or relapse (Approximately up to 5 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
Gender
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
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
Blinded (masking 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 - Perth
Recruitment postcode(s) [1] 0 0
4101 - Sth Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6011 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Colorado
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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 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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Texas
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Utah
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Virginia
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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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United Kingdom
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Cambridgeshire
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Glamorgan
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Grampian
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Greater London
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United Kingdom
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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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United Kingdom
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Tyne and Wear
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United Kingdom
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WEST Midlands

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 - European Intergroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukaemia with Imatinib
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/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