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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
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated
Trial website
https://clinicaltrials.gov/study/NCT00777036
Trial related presentations / publications
Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00777036