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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
27/07/2018

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
Percentage of Participants With 3-year Event-free Survival (EFS) - 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
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Percentage of Participants With 3-year EFS Rate (K-M Estimate) - 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.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Overall Survival (K-M Estimate) Rate at 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.
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Complete Remission Rate - 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.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Percentage of Participants With Minimal Residual Disease Based on Ig/TCR Method - 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.
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Number of Participants With AEs or Drug Related Death - The number of participants with any AE or with study drug-related death was reported for each arm.
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Number of Participants With BCR-ABL Mutations at Time of Disease Progression - The number of Ph+ ALL participants with BCR-ABL Mutations at Disease Progression or Relapse was reported for each arm.
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Number of Participants With Grade 3-4 Hematology Laboratory Abnormalities. - The number of participants experiencing Grade 3 or 4 hematology laboratory abnormalities was reported by arm.
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Number of Participants With Grade 3-4 Liver Function Laboratory Abnormalities. - The number of participants experiencing Grade 3 or 4 liver function laboratory abnormalities was reported by arm.
Timepoint [8] 0 0
Approximately 3 years
Secondary outcome [9] 0 0
Number of Participants With Grade 3-4 Kidney Function Abnormalities - The number of participants experiencing Grade 3 or 4 kidney function laboratory abnormalities was reported by arm.
Timepoint [9] 0 0
Approximately 3 years
Secondary outcome [10] 0 0
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities - The number of participants with grade 3-4 serum chemistry laboratory abnormalities was presented for each arm.
Timepoint [10] 0 0
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
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
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
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
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
Country [5] 0 0
United States of America
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Colorado
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United States of America
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Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
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State/province [22] 0 0
Nevada
Country [23] 0 0
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State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
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State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
Rhode Island
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
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United States of America
State/province [37] 0 0
Wisconsin
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Canada
State/province [41] 0 0
Saskatchewan
Country [42] 0 0
Italy
State/province [42] 0 0
Bologna
Country [43] 0 0
Italy
State/province [43] 0 0
Cagliari
Country [44] 0 0
Italy
State/province [44] 0 0
Catania
Country [45] 0 0
Italy
State/province [45] 0 0
Firenze
Country [46] 0 0
Italy
State/province [46] 0 0
Genova
Country [47] 0 0
Italy
State/province [47] 0 0
Monza
Country [48] 0 0
Italy
State/province [48] 0 0
Napoli
Country [49] 0 0
Italy
State/province [49] 0 0
Palermo
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Italy
State/province [52] 0 0
Trieste
Country [53] 0 0
Puerto Rico
State/province [53] 0 0
San Juan
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Avon
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Cambridgeshire
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Glamorgan
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Grampian
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Greater London
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Greater Manchester
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Hampshire
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Lanarkshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Lothian
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United Kingdom
State/province [63] 0 0
Merseyside
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United Kingdom
State/province [64] 0 0
North Yorkshire
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Nottinghamshire
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Oxfordshire
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United Kingdom
State/province [67] 0 0
South Yorkshire
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Surrey
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Tyne and Wear
Country [70] 0 0
United Kingdom
State/province [70] 0 0
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