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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

Phase 2
1 Year
17 Years
Open (Enrolling)
Leukemia, Pediatric

Thank you

Trial Information

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

Inclusion Criteria:

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival (EFS) rate at 3 years of Dasatinib plus chemotherapy compared with external historical controls

Outcome Time Frame:

Three years following the 75th patient's first visit

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

February 2022

Related Keywords:

  • Leukemia, Pediatric
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome



Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hospital of MichiganDetroit, Michigan  48201
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Medical College of WisconsinMilwaukee, Wisconsin  53226
New York Medical CollegeValhalla, New York  10595
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Washington University Medical CenterSaint Louis, Missouri  63105
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Driscoll Children's HospitalCorpus Christi, Texas  78466
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Lee Memorial Health SystemFort Myers, Florida  33902
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Connecticut Children's Medical CenterHartford, Connecticut  06106
SUNY Upstate Medical UniversitySyracuse, New York  13210
Mercy Children's HospitalToledo, Ohio  43608
Dana Farber Cancer InstituteBoston, Massachusetts  02115
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Penn State Hershey Medical CenterHershey, Pennsylvania  17033
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UT SouthwesternDallas, Texas  75390
Cook Children's Medical CenterFort Worth, Texas  76104
The Children's Medical Center of DaytonDayton, Ohio  45404
St. Joseph's Regional Medical CenterPaterson, New Jersey  07503
Levine Children's HospitalCharlotte, North Carolina  28204
Legacy Emanuel Hospital & Health CenterPortland, Oregon  97210
Children's Hospital ColoradoAurora, Colorado  80045
Children's Specialty Center of NevadaLas Vegas, Nevada  89109
Scott & White HealthcareTemple, Texas  76508
The Children's Mercy Hospital and ClinicsKansas City, Missouri  64108
A. I. duPont Hospital for ChildrenWilmington, Delaware  19803
Univ Of Mississippi Med CtrJackson, Mississippi  39216
East Tennessee Children'S HospKnoxville, Tennessee  37916
Children's Center for Cancer and Blood DiseasesIndianapolis, Indiana  46260
Antranik Agop BedrosLoma Linda, California  92350
Miller Children's Hospital Long BeachLong Beach, California  90806
Children'S Hospital Of L.A.Los Angeles, California  90027
Lpch & SumcPalo Alto, California  94304
Kaiser Medical CenterRoseville, California  95661
Children'S Hospital Of ChicagoChicago, Illinois  60611
James Whitcomb Riley Hospital For ChildrenIndianapolis, Indiana  46202-5225
Goryeb Children'S HospitalMorristown, New Jersey  07962
Baylor College Of Med/Tx Chldrns Cancer & Hem Ctrs.Houston, Texas  77030
Children'S Hosp-Kings DaughterNorfolk, Virginia  23507
St Vincent HospitalGreen Bay, Wisconsin  54301