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
2 other identifiers
interventional
133
18 countries
174
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Mar 2009
Longer than P75 for phase_2 leukemia
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedStudy Start
First participant enrolled
March 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedResults Posted
Study results publicly available
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2025
CompletedAugust 29, 2025
August 1, 2025
7.5 years
October 21, 2008
December 6, 2017
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Major Cytogenetic Response (MCyR) Rate
Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Hematologic Response (CHR) Rate
Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Cytogenetic Response (CCyR) Rate
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary Outcomes (18)
Major Cytogenetic Response (MCyR) Rate in Cohort 2
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Rate of Best Cytogenetic Response
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Time to Major Cytogenetic Response (MCyR)
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Duration of Major Cytogenetic Response (MCyR)
From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
- +13 more secondary outcomes
Study Arms (3)
Cohort 1: Imatinib-resistant/intolerant CP-CML
EXPERIMENTALDasatinib 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
Cohort 2: Ph+ALL or AP- or BP-CML
EXPERIMENTALDasatinib 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
Cohort 3: Newly diagnosed, treatment naïve CP-CML
EXPERIMENTALDasatinib 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (174)
Local Institution
Birmingham, Alabama, 35233, United States
Local Institution - 0005
Phoenix, Arizona, 85016, United States
Phoenix Children'S Hospital
Phoenix, Arizona, 85016, United States
Jonathan Jaques Children'S Cancer Center
Long Beach, California, 90801-1428, United States
Jonathan Jaques Children'S Cancer Center
Long Beach, California, 90806, United States
Local Institution - 0001
Long Beach, California, 90806, United States
Children'S Hospital Of Orange County
Orange, California, 92868, United States
Local Institution - 0024
Orange, California, 92868, United States
Children'S Hospital
Aurora, Colorado, 80045, United States
Local Institution - 0004
Aurora, Colorado, 80045, United States
Children's Healthcare Of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Local Institution - 047
Atlanta, Georgia, 30322, United States
Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Local Institution - 0072
Chicago, Illinois, 60611, United States
Local Institution
Chicago, Illinois, 60611, United States
Dana Faber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215, United States
Local Institution - 0040
Boston, Massachusetts, 02215, United States
Stephen D. Hassenfeld Children'S Center
New York, New York, 10016, United States
Local Institution - 0061
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Oregon Health & Sci Univ
Portland, Oregon, 97239-3098, United States
Local Institution - 0002
Portland, Oregon, 97239, United States
Oregon Health & Sci Univ
Portland, Oregon, 97239, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104-4318, United States
Local Institution - 0014
Philadelphia, Pennsylvania, 19104-4318, United States
Children'S Hospital Of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, 15224, United States
Local Institution - 0035
Houston, Texas, 77030-4009, United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Local Institution - 0048
Houston, Texas, 77030, United States
Texas Children'S Cancer Center
Houston, Texas, 77030, United States
Local Institution - 0028
Seattle, Washington, 98105, United States
Seattle Children'S
Seattle, Washington, 98105, United States
Local Institution - 0043
Bunos Aires, Buenos Aires, 1425, Argentina
Local Institution
Bunos Aires, Buenos Aires, 1425, Argentina
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, 1684, Argentina
Local Institution - 0049
El Palomar, Buenos Aires, 1684, Argentina
Local Institution - 0042
Córdoba, 5016, Argentina
Local Institution
Córdoba, 5016, Argentina
Local Institution - 065
Randwick, New South Wales, 2031, Australia
Local Institution
Randwick, New South Wales, 2031, Australia
Local Institution - 069
Westmead, New South Wales, 2145, Australia
Local Institution
Westmead, New South Wales, 2145, Australia
Local Institution - 0064
Sth Brisbane, Queensland, 4101, Australia
Local Institution
Sth Brisbane, Queensland, 4101, Australia
Local Institution - 067
North Adelaide, South Australia, 5006, Australia
Local Institution
North Adelaide, South Australia, 5006, Australia
Local Institution - 0066
Parkville, Victoria, 3052, Australia
Local Institution
Parkville, Victoria, 3052, Australia
Local Institution - 0021
Curitiba, Paraná, 80060-900, Brazil
Local Institution
Curitiba, Paraná, 80060-900, Brazil
Local Institution - 0022
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Local Institution - 0019
São Paulo, São Paulo, 04520-013, Brazil
Local Institution - 0020
Campinas, 13083-970, Brazil
Local Institution
Campinas, 13083-970, Brazil
Local Institution - 0039
São Paulo, 01401-000, Brazil
Local Institution
São Paulo, 01401-000, Brazil
Local Institution
São Paulo, 04023-062, Brazil
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8, Canada
Local Institution - 0079
Calgary, Alberta, T3B 6A8, Canada
Local Institution - 0078
Edmonton, Alberta, T6G 2B7, Canada
Stollery Children'S Hospital
Edmonton, Alberta, T6G 2B7, Canada
Bc Children'S Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Local Institution - 077
Vancouver, British Columbia, V6H 3V4, Canada
Iwk Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
Local Institution - 073
Halifax, Nova Scotia, B3K 6R8, Canada
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Local Institution - 086
Ottawa, Ontario, K1H 8L1, Canada
Local Institution - 076
Toronto, Ontario, M5G 1X8, Canada
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Chu Ste-Justine
Montreal, Quebec, H3T 1C5, Canada
Local Institution - 080
Montreal, Quebec, H3T 1C5, Canada
Local Institution - 0030
Lyon, 69008, France
Local Institution
Lyon, 69008, France
Local Institution - 0032
Nantes, 44093, France
Local Institution
Nantes, 44093, France
Local Institution - 0037
Paris, 75012, France
Local Institution
Paris, 75012, France
Local Institution
Paris, 75571, France
Local Institution - 0029
Paris, 75935, France
Local Institution
Paris, 75935, France
Local Institution - 036
Poitiers, 86000, France
Local Institution
Poitiers, 86000, France
Local Institution - 075
Frankfurt, 60590, Germany
Local Institution
Frankfurt, 60590, Germany
Local Institution - 0074
Hanover, 30625, Germany
Local Institution
Hanover, 30625, Germany
Local Institution - 0089
Navrangpura, Ahmedabad, Gujarat, 380009, India
Local Institution
Navrangpura, Ahmedabad, Gujarat, 380009, India
Local Institution
Bangalore, Karnataka, 560027, India
Local Institution
Mumbai, Maharashtra, 400010, India
Local Institution - 0094
Pune, Maharashtra, 411001, India
Local Institution
Pune, Maharashtra, 411001, India
Local Institution - 0093
Madurai, Tamil Nadu, 625107, India
Local Institution
Madurai, Tamil Nadu, 625107, India
Local Institution
Vellore, Tamil Nadu, 632004, India
Local Institution - 0088
Bangalore, 560027, India
Local Institution - 0082
Kolkata, 700 016, India
Local Institution
Kolkata, 700 016, India
Local Institution - 0085
Mumbai, 400010, India
Local Institution
Mumbai, 400010, India
Local Institution - 0084
Trivandrum, 695011, India
Local Institution
Trivandrum, 695011, India
Local Institution - 038
Bologna, 40138, Italy
Local Institution
Bologna, 40138, Italy
Local Institution - 006
Monza, 20900, Italy
Local Institution
Monza (MB), 20900, Italy
Local Institution - 070
Roma, 00161, Italy
Local Institution
Roma, 00161, Italy
Local Institution - 0059
Roma, 00165, Italy
Local Institution
Roma, 00165, Italy
Local Institution - 015
Torino, 10126, Italy
Local Institution
Torino, 10126, Italy
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340, Mexico
Local Institution - 0054
Guadalajara, Jalisco, 44340, Mexico
Local Institution - 0051
Cuauhtémoc, Mexico City, 06720, Mexico
Local Institution
Df, Mexico City, 06720, Mexico
Local Institution - 0053
Mexico City, Mexico City, 04530, Mexico
Local Institution
Mexico City, Mexico City, 04530, Mexico
Local Institution - 0052
Mexico City, Mexico City, 06726, Mexico
Local Institution
Mexico City, Mexico City, 06726, Mexico
Local Institution
Mexico, D. F., Mexico City, 06726, Mexico
Local Institution - 0050
Monterrey, Nuevo León, 64460, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Local Institution - 0060
Monterrey, N.l., Nuevo León, 64180, Mexico
Local Institution
Monterrey, N.l., Nuevo León, 64180, Mexico
Local Institution - 0007
Rotterdam, 3015 GJ, Netherlands
Local Institution
Rotterdam, 3015 GJ, Netherlands
Local Institution - 0099
Utrecht, 3584 CS, Netherlands
Local Institution - 0095
Bucharest, 022322, Romania
Local Institution
Bucharest, 022322, Romania
Local Institution - 0097
Sector 2, 022328, Romania
Local Institution - 0017
Moscow, 115478, Russia
Local Institution
Moscow, 115478, Russia
Local Institution - 0023
Moscow, 117198, Russia
Local Institution
Moscow, 117198, Russia
Local Institution - 0018
Saint Petersburg, 197022, Russia
Local Institution
Saint Petersburg, 197022, Russia
Local Institution - 0071
Singapore, 119074, Singapore
Local Institution
Singapore, 119228, Singapore
Local Institution - 0055
Bloemfontein, Free State, 9301, South Africa
Local Institution
Bloemfontein, Free State, 9301, South Africa
Local Institution - 058
Pretoria, Gauteng, 0001, South Africa
Local Institution
Pretoria, Gauteng, 0001, South Africa
Local Institution - 0057
Cape Town, Western Cape, 7925, South Africa
Local Institution
Cape Town, Western Cape, 7925, South Africa
Local Institution - 062
Tygerberg, Western Cape, 7505, South Africa
Local Institution
Tygerberg, Western Cape, 7505, South Africa
Local Institution - 0092
Seoul, 05505, South Korea
Local Institution
Seoul, 05505, South Korea
Local Institution - 0091
Seoul, 137-701, South Korea
Local Institution
Seoul, 137-701, South Korea
Local Institution - 0013
Barcelona, 08025, Spain
Local Institution
Barcelona, 08025, Spain
Local Institution - 0012
Barcelona, 08035, Spain
Local Institution
Barcelona, 08035, Spain
Local Institution - 0011
Madrid, 28009, Spain
Local Institution
Madrid, 28009, Spain
Local Institution - 0010
Madrid, 28046, Spain
Local Institution
Madrid, 28046, Spain
Local Institution - 0041
Málaga, 29010, Spain
Local Institution
Málaga, 29010, Spain
Local Institution - 0033
Valencia, 46009, Spain
Local Institution
Valencia, 46009, Spain
Local Institution
Valencia, Spain
Local Institution - 0016
Glasgow, Central, G3 8SJ, United Kingdom
Local Institution
Glasgow, Central, G3 8SJ, United Kingdom
Local Institution - 0009
Sutton, Surrey, SM2 5PT, United Kingdom
Local Institution
Sutton, Surrey, SM2 5PT, United Kingdom
Local Institution - 0008
Birmingham, West Midlands, B4 6NH, United Kingdom
Local Institution
Birmingham, West Midlands, B4 6NH, United Kingdom
Related Publications (1)
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.
PMID: 29498925DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
March 20, 2009
Primary Completion
September 1, 2016
Study Completion
January 27, 2025
Last Updated
August 29, 2025
Results First Posted
January 5, 2018
Record last verified: 2025-08