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
NCT ID: NCT00777036
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2009-03-20
2025-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Dasatinib
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
Dasatinib
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
Dasatinib
Interventions
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Dasatinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Day
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Birmingham, Alabama, United States
Local Institution - 0005
Phoenix, Arizona, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Jonathan Jaques Children'S Cancer Center
Long Beach, California, United States
Jonathan Jaques Children'S Cancer Center
Long Beach, California, United States
Local Institution - 0001
Long Beach, California, United States
Children'S Hospital Of Orange County
Orange, California, United States
Local Institution - 0024
Orange, California, United States
Children'S Hospital
Aurora, Colorado, United States
Local Institution - 0004
Aurora, Colorado, United States
Children's Healthcare Of Atlanta - Egleston
Atlanta, Georgia, United States
Local Institution - 047
Atlanta, Georgia, United States
Children's Hospital of Chicago
Chicago, Illinois, United States
Local Institution - 0072
Chicago, Illinois, United States
Local Institution
Chicago, Illinois, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, United States
Local Institution - 0040
Boston, Massachusetts, United States
Stephen D. Hassenfeld Children'S Center
New York, New York, United States
Local Institution - 0061
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Oregon Health & Sci Univ
Portland, Oregon, United States
Local Institution - 0002
Portland, Oregon, United States
Oregon Health & Sci Univ
Portland, Oregon, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Local Institution - 0014
Philadelphia, Pennsylvania, United States
Children'S Hospital Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, United States
Local Institution - 0035
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0048
Houston, Texas, United States
Texas Children'S Cancer Center
Houston, Texas, United States
Local Institution - 0028
Seattle, Washington, United States
Seattle Children'S
Seattle, Washington, United States
Local Institution - 0043
Bunos Aires, Buenos Aires, Argentina
Local Institution
Bunos Aires, Buenos Aires, Argentina
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, Argentina
Local Institution - 0049
El Palomar, Buenos Aires, Argentina
Local Institution - 0042
Córdoba, , Argentina
Local Institution
Córdoba, , Argentina
Local Institution - 065
Randwick, New South Wales, Australia
Local Institution
Randwick, New South Wales, Australia
Local Institution - 069
Westmead, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Local Institution - 0064
Sth Brisbane, Queensland, Australia
Local Institution
Sth Brisbane, Queensland, Australia
Local Institution - 067
North Adelaide, South Australia, Australia
Local Institution
North Adelaide, South Australia, Australia
Local Institution - 0066
Parkville, Victoria, Australia
Local Institution
Parkville, Victoria, Australia
Local Institution - 0021
Curitiba, Paraná, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution - 0022
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0019
São Paulo, São Paulo, Brazil
Local Institution - 0020
Campinas, , Brazil
Local Institution
Campinas, , Brazil
Local Institution - 0039
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Alberta Children'S Hospital
Calgary, Alberta, Canada
Local Institution - 0079
Calgary, Alberta, Canada
Local Institution - 0078
Edmonton, Alberta, Canada
Stollery Children'S Hospital
Edmonton, Alberta, Canada
Bc Children'S Hospital
Vancouver, British Columbia, Canada
Local Institution - 077
Vancouver, British Columbia, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Local Institution - 073
Halifax, Nova Scotia, Canada
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, Canada
Local Institution - 086
Ottawa, Ontario, Canada
Local Institution - 076
Toronto, Ontario, Canada
The Hospital For Sick Children
Toronto, Ontario, Canada
Chu Ste-Justine
Montreal, Quebec, Canada
Local Institution - 080
Montreal, Quebec, Canada
Local Institution - 0030
Lyon, , France
Local Institution
Lyon, , France
Local Institution - 0032
Nantes, , France
Local Institution
Nantes, , France
Local Institution - 0037
Paris, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution - 0029
Paris, , France
Local Institution
Paris, , France
Local Institution - 036
Poitiers, , France
Local Institution
Poitiers, , France
Local Institution - 075
Frankfurt, , Germany
Local Institution
Frankfurt, , Germany
Local Institution - 0074
Hanover, , Germany
Local Institution
Hanover, , Germany
Local Institution - 0089
Navrangpura, Ahmedabad, Gujarat, India
Local Institution
Navrangpura, Ahmedabad, Gujarat, India
Local Institution
Bangalore, Karnataka, India
Local Institution
Mumbai, Maharashtra, India
Local Institution - 0094
Pune, Maharashtra, India
Local Institution
Pune, Maharashtra, India
Local Institution - 0093
Madurai, Tamil Nadu, India
Local Institution
Madurai, Tamil Nadu, India
Local Institution
Vellore, Tamil Nadu, India
Local Institution - 0088
Bangalore, , India
Local Institution - 0082
Kolkata, , India
Local Institution
Kolkata, , India
Local Institution - 0085
Mumbai, , India
Local Institution
Mumbai, , India
Local Institution - 0084
Trivandrum, , India
Local Institution
Trivandrum, , India
Local Institution - 038
Bologna, , Italy
Local Institution
Bologna, , Italy
Local Institution - 006
Monza, , Italy
Local Institution
Monza (MB), , Italy
Local Institution - 070
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution - 0059
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution - 015
Torino, , Italy
Local Institution
Torino, , Italy
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
Local Institution - 0054
Guadalajara, Jalisco, Mexico
Local Institution - 0051
Cuauhtémoc, Mexico City, Mexico
Local Institution
Df, Mexico City, Mexico
Local Institution - 0053
Mexico City, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution - 0052
Mexico City, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Mexico, D. F., Mexico City, Mexico
Local Institution - 0050
Monterrey, Nuevo León, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution - 0060
Monterrey, N.l., Nuevo León, Mexico
Local Institution
Monterrey, N.l., Nuevo León, Mexico
Local Institution - 0007
Rotterdam, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution - 0099
Utrecht, , Netherlands
Local Institution - 0095
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution - 0097
Sector 2, , Romania
Local Institution - 0017
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution - 0023
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution - 0018
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution - 0071
Singapore, , Singapore
Local Institution
Singapore, , Singapore
Local Institution - 0055
Bloemfontein, Free State, South Africa
Local Institution
Bloemfontein, Free State, South Africa
Local Institution - 058
Pretoria, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution - 0057
Cape Town, Western Cape, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution - 062
Tygerberg, Western Cape, South Africa
Local Institution
Tygerberg, Western Cape, South Africa
Local Institution - 0092
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution - 0091
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution - 0013
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution - 0012
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution - 0011
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution - 0010
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution - 0041
Málaga, , Spain
Local Institution
Málaga, , Spain
Local Institution - 0033
Valencia, , Spain
Local Institution
Valencia, , Spain
Local Institution
Valencia, , Spain
Local Institution - 0016
Glasgow, Central, United Kingdom
Local Institution
Glasgow, Central, United Kingdom
Local Institution - 0009
Sutton, Surrey, United Kingdom
Local Institution
Sutton, Surrey, United Kingdom
Local Institution - 0008
Birmingham, West Midlands, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2008-002260-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA180-226
Identifier Type: -
Identifier Source: org_study_id
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