Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT01460160
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
- Extramedullary involvement of the testicles
- Active systemic bacterial, fungal or viral infection
- Down syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Dasatinib Dasatinib -
- Primary Outcome Measures
Name Time Method 3-year Event-free Survival (EFS) Rate From first dose to 3 years following first dose 3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment.
Events for EFS are defined as ANY first one of the following:
* Lack of complete response in bone marrow
* Relapse at any site
* Development of second malignant neoplasm
* Death from any cause
- Secondary Outcome Measures
Name Time Method Percentage of Participants Negative for Minimal Residual Disease (MRD) From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
Complete Remission Rate From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) From first dose to 3 years or 5 years following first dose Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
Number of Participants Experiencing Adverse Events From first dose to 100 days following last dose (up to approximately 23 months) Number of participants experiencing different types of all causality all grade adverse events
Trial Locations
- Locations (94)
University Of Arkansas For Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Miller Children's and Women Hospital
🇺🇸Long Beach, California, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
All Children'S Hospital
🇺🇸Saint Petersburg, Florida, United States
Antranik Agop Bedros
🇺🇸Loma Linda, California, United States
Children'S Hospital Of L.A.
🇺🇸Los Angeles, California, United States
The Herbert Irving Pavilion
🇺🇸New York, New York, United States
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
The Cancer Institute Of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
New York University
🇺🇸New York, New York, United States
Kaiser Medical Center
🇺🇸Roseville, California, United States
University Of Missouri Health Care
🇺🇸Columbia, Missouri, United States
A. I. Dupont Hospital For Children
🇺🇸Wilmington, Delaware, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Helen Devos Children'S Hospital
🇺🇸Grand Rapids, Michigan, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Children'S Hospital Of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Mary'S
🇺🇸West Palm Beach, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Ut Southwestern
🇺🇸Dallas, Texas, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
St Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Nationwide Children'S Hospital
🇺🇸Columbus, Ohio, United States
Goryeb Children'S Hospital
🇺🇸Morristown, New Jersey, United States
The Children'S Medical Center Of Dayton
🇺🇸Dayton, Ohio, United States
Children's Hospital Of Pittsburgh Of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Scott & White - McLane Children's Specialty Clinic
🇺🇸Temple, Texas, United States
Alberta Children'S Hospital
🇨🇦Calgary, Alberta, Canada
Mercy Children's Hospital
🇺🇸Toledo, Ohio, United States
Cook Children'S Hem/Onc Center
🇺🇸Fort Worth, Texas, United States
New York Presbyterian/Weill Cornell
🇺🇸New York, New York, United States
Inova Pediatric Specialty Center Ii
🇺🇸Fairfax, Virginia, United States
Driscoll Children'S Hospital
🇺🇸Corpus Christi, Texas, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Children'S Hosp-Kings Daughter
🇺🇸Norfolk, Virginia, United States
East Tennessee Children'S Hosp
🇺🇸Knoxville, Tennessee, United States
The Toledo Children'S Hospital
🇺🇸Toledo, Ohio, United States
The Montreal Children's Hospital of the MUHC
🇨🇦Montreal, Quebec, Canada
Chu Ste-Justine
🇨🇦Montreal, Quebec, Canada
Children'S Hospital Of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Local Institution
🇬🇧Cambridge, United Kingdom
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
James Whitcomb Riley Hospital For Children
🇺🇸Indianapolis, Indiana, United States
Children'S Center For Cancer And Blood Diseases
🇺🇸Indianapolis, Indiana, United States
Children'S Specialty Center Of Nevada
🇺🇸Las Vegas, Nevada, United States
Cincinnati Children'S Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Children'S Cancer Center
🇺🇸Houston, Texas, United States
Seattle Children'S
🇺🇸Seattle, Washington, United States
Childrens Hospitals And Clinics Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Ucsf - Hematology/Oncology
🇺🇸San Francisco, California, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Children'S Hospital Of Michigan
🇺🇸Detroit, Michigan, United States
University Of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Joseph's Children's Hospital
🇺🇸Tampa, Florida, United States
Legacy Emanuel Hospital & Health Center
🇺🇸Portland, Oregon, United States
Oregon Health & Sci Univ
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
🇺🇸Phoenix, Arizona, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lpch & Sumc
🇺🇸Palo Alto, California, United States
Nemours Children'S Clinic
🇺🇸Jacksonville, Florida, United States
Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Children's Healthcare Of Atlanta
🇺🇸Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital Of Chicago
🇺🇸Chicago, Illinois, United States
Southern Illinois University School Of Medicine
🇺🇸Springfield, Illinois, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Univ Of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
St. Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
Children'S Hospital Colorado
🇺🇸Aurora, Colorado, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Md Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Norton Children's Hospital
🇺🇸Louisville, Kentucky, United States
Nemours Childrens Hospital
🇺🇸Orlando, Florida, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Children'S Mercy Hospital And Clinics
🇺🇸Kansas City, Missouri, United States
Children'S National Medical Center
🇺🇸Washington, District of Columbia, United States
Sinai Hospital Of Baltimore
🇺🇸Baltimore, Maryland, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
Kapiolani Medical Center For Women & Children
🇺🇸Honolulu, Hawaii, United States
University Of Kentucky
🇺🇸Lexington, Kentucky, United States
University Of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Dell Children'S Medical Center Of Central Texas
🇺🇸Austin, Texas, United States
Kenneth Desantes, Md
🇺🇸Madison, Wisconsin, United States
Stollery Children'S Hospital
🇨🇦Edmonton, Alberta, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States