Know Cancer

forgot password

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 Philadelphia Philadelphia, Pennsylvania  19104
Children's Hospital of Michigan Detroit, Michigan  48201
Geisinger Medical Center Danville, Pennsylvania  17822-0001
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Medical College of Wisconsin Milwaukee, Wisconsin  53226
New York Medical College Valhalla, New York  10595
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Nemours Children's Clinic Jacksonville, Florida  32207
All Children's Hospital St. Petersburg, Florida  33701
Washington University Medical Center Saint Louis, Missouri  63105
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Driscoll Children's Hospital Corpus Christi, Texas  78466
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central Texas Austin, Texas  78723
Lee Memorial Health System Fort Myers, Florida  33902
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Connecticut Children's Medical Center Hartford, Connecticut  06106
SUNY Upstate Medical University Syracuse, New York  13210
Mercy Children's Hospital Toledo, Ohio  43608
Dana Farber Cancer Institute Boston, Massachusetts  02115
Local Institution Chicago, Illinois  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Portland, Oregon  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
Local Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Local Institution Lincoln, Nebraska  
Local Institution New Brunswick, New Jersey  
Local Institution Albuquerque, New Mexico  
Local Institution Wilmington, North Carolina  
Local Institution Austin, Texas  
Local Institution Arlington, Virginia  
Local Institution Rome, Georgia  
Local Institution New Orleans, Louisiana  
Penn State Hershey Medical Center Hershey, Pennsylvania  17033
Local Institution Providence, Rhode Island  
Local Institution Chattanooga, Tennessee  
Local Institution Salt Lake City, Utah  
Local Institution Columbia, Missouri  
Local Institution Boise, Idaho  
Local Institution Iowa City, Iowa  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan  
Local Institution Honolulu, Hawaii  
UT Southwestern Dallas, Texas  75390
Cook Children's Medical Center Fort Worth, Texas  76104
The Children's Medical Center of Dayton Dayton, Ohio  45404
St. Joseph's Regional Medical Center Paterson, New Jersey  07503
Levine Children's Hospital Charlotte, North Carolina  28204
Legacy Emanuel Hospital & Health Center Portland, Oregon  97210
Children's Hospital Colorado Aurora, Colorado  80045
Children's Specialty Center of Nevada Las Vegas, Nevada  89109
Scott & White Healthcare Temple, Texas  76508
The Children's Mercy Hospital and Clinics Kansas City, Missouri  64108
A. I. duPont Hospital for Children Wilmington, Delaware  19803
Univ Of Mississippi Med Ctr Jackson, Mississippi  39216
East Tennessee Children'S Hosp Knoxville, Tennessee  37916
Children's Center for Cancer and Blood Diseases Indianapolis, Indiana  46260
Antranik Agop Bedros Loma Linda, California  92350
Miller Children's Hospital Long Beach Long Beach, California  90806
Children'S Hospital Of L.A. Los Angeles, California  90027
Lpch & Sumc Palo Alto, California  94304
Kaiser Medical Center Roseville, California  95661
Children'S Hospital Of Chicago Chicago, Illinois  60611
James Whitcomb Riley Hospital For Children Indianapolis, Indiana  46202-5225
Goryeb Children'S Hospital Morristown, New Jersey  07962
Baylor College Of Med/Tx Chldrns Cancer & Hem Ctrs. Houston, Texas  77030
Children'S Hosp-Kings Daughter Norfolk, Virginia  23507
St Vincent Hospital Green Bay, Wisconsin  54301