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
1 Year
17 Years
Open (Enrolling)
Both
Leukemia, Pediatric
Both
Leukemia, Pediatric
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:
Interventional
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:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA180-372
NCT ID:
NCT01460160
Start Date:
April 2012
Completion Date:
February 2022
Related Keywords:
- Leukemia, Pediatric
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Philadelphia Chromosome
Name | Location |
|---|---|
| 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 |
