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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00777036




Registration number
NCT00777036
Ethics application status
Date submitted
21/10/2008
Date registered
22/10/2008
Date last updated
13/09/2023

Titles & IDs
Public title
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Scientific title
A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Secondary ID [1] 0 0
2008-002260-33
Secondary ID [2] 0 0
CA180-226
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Cohort 1: Imatinib-resistant/intolerant CP-CML - Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Experimental: Cohort 2: Ph+ALL or AP- or BP-CML - Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML - Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Cytogenetic Response (MCyR) Rate
Timepoint [1] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Primary outcome [2] 0 0
Complete Hematologic Response (CHR) Rate
Timepoint [2] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Primary outcome [3] 0 0
Complete Cytogenetic Response (CCyR) Rate
Timepoint [3] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary outcome [1] 0 0
Major Cytogenetic Response (MCyR) Rate in Cohort 2
Timepoint [1] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary outcome [2] 0 0
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
Timepoint [2] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary outcome [3] 0 0
Rate of Best Cytogenetic Response
Timepoint [3] 0 0
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary outcome [4] 0 0
Time to Major Cytogenetic Response (MCyR)
Timepoint [4] 0 0
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Secondary outcome [5] 0 0
Duration of Major Cytogenetic Response (MCyR)
Timepoint [5] 0 0
From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
Secondary outcome [6] 0 0
Time to Complete Cytogenetic Response (CCyR)
Timepoint [6] 0 0
From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
Secondary outcome [7] 0 0
Duration of Complete Cytogenetic Response (CCyR)
Timepoint [7] 0 0
From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
Secondary outcome [8] 0 0
Progression-Free Survival (PFS) Rate at 2 Years
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Time to Complete Hematologic Response (CHR)
Timepoint [9] 0 0
From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
Secondary outcome [10] 0 0
Duration of Complete Hemotologic Response (CHR)
Timepoint [10] 0 0
From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
Secondary outcome [11] 0 0
Disease-Free Survival Rate at 2 Years
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Overall Survival (OS) Rate at 2 Years
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Major Molecular Response (MMR) Rate
Timepoint [13] 0 0
From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)
Secondary outcome [14] 0 0
Complete Molecular Response (CMR) Rate
Timepoint [14] 0 0
From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)
Secondary outcome [15] 0 0
Major Cytogenetic Response (MCyR) Rate up to 2 Years
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Timepoint [16] 0 0
24 months
Secondary outcome [17] 0 0
Major Molecular Response (MMR) Rate up to 2 Years
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Complete Molecular Response (CMR) Rate up to 2 Years
Timepoint [18] 0 0
24 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
* Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
* Newly diagnosed, treatment naive CP-CML (Cohort 3)
* Lansky or Karnofsky scale >50
* Life expectancy =12 weeks
* Adequate hepatic and renal function
* Written informed consent
* Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
* Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
* Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
* Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
* Target Population for the PK substudy subjects must meet relevant inclusion criteria
Minimum age
1 Day
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
* Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
* Isolated extramedullary disease
* Prior therapy with Dasatinib
* Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
* Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Other inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
20/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/12/2029
Actual
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 065 - Randwick
Recruitment hospital [2] 0 0
Local Institution - Randwick
Recruitment hospital [3] 0 0
Local Institution - 069 - Westmead
Recruitment hospital [4] 0 0
Local Institution - Westmead
Recruitment hospital [5] 0 0
Local Institution - 0064 - Sth Brisbane
Recruitment hospital [6] 0 0
Local Institution - Sth Brisbane
Recruitment hospital [7] 0 0
Local Institution - 067 - North Adelaide
Recruitment hospital [8] 0 0
Local Institution - North Adelaide
Recruitment hospital [9] 0 0
Local Institution - 0066 - Parkville
Recruitment hospital [10] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - Sth Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
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
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Brazil
State/province [15] 0 0
Parana
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
SAO Paulo
Country [18] 0 0
Brazil
State/province [18] 0 0
Campinas
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Paris Cedex 12
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Poitiers
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Hannover
Country [32] 0 0
India
State/province [32] 0 0
Gujarat
Country [33] 0 0
India
State/province [33] 0 0
Karnataka
Country [34] 0 0
India
State/province [34] 0 0
Maharashtra
Country [35] 0 0
India
State/province [35] 0 0
Tamil Nadu
Country [36] 0 0
India
State/province [36] 0 0
Tamilnadu
Country [37] 0 0
India
State/province [37] 0 0
Bangalore
Country [38] 0 0
India
State/province [38] 0 0
Kolkatta
Country [39] 0 0
India
State/province [39] 0 0
Mumbai
Country [40] 0 0
India
State/province [40] 0 0
Trivandrum
Country [41] 0 0
Italy
State/province [41] 0 0
Bologna
Country [42] 0 0
Italy
State/province [42] 0 0
Monza (MB)
Country [43] 0 0
Italy
State/province [43] 0 0
Monza
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Torino
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Mexico
State/province [47] 0 0
Distrito Federal
Country [48] 0 0
Mexico
State/province [48] 0 0
Jalisco
Country [49] 0 0
Mexico
State/province [49] 0 0
Nuevo Leon
Country [50] 0 0
Netherlands
State/province [50] 0 0
Rotterdam
Country [51] 0 0
Netherlands
State/province [51] 0 0
Utrecht
Country [52] 0 0
Romania
State/province [52] 0 0
Bucharest
Country [53] 0 0
Romania
State/province [53] 0 0
Sector 2
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Saint-petersburg
Country [56] 0 0
Singapore
State/province [56] 0 0
Singapore
Country [57] 0 0
South Africa
State/province [57] 0 0
FREE State
Country [58] 0 0
South Africa
State/province [58] 0 0
Gauteng
Country [59] 0 0
South Africa
State/province [59] 0 0
Western CAPE
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Malaga
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Central
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Surrey
Country [66] 0 0
United Kingdom
State/province [66] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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?

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/study/NCT00777036