Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
NCT ID: NCT01460160
Last Updated: 2021-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2012-04-13
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Dasatinib
Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Interventions
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Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Extramedullary involvement of the testicles
* Active systemic bacterial, fungal or viral infection
* Down syndrome
1 Year
17 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
EsPhALL
OTHER
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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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix, Arizona, United States
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
Antranik Agop Bedros
Loma Linda, California, United States
Miller Children's and Women Hospital
Long Beach, California, United States
Children'S Hospital Of L.A.
Los Angeles, California, United States
Southern California Permanente Medical Group
Los Angeles, California, 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
Kaiser Medical Center
Roseville, California, United States
Ucsf - Hematology/Oncology
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
A. I. Dupont Hospital For Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Lee Memorial Health System
Fort Myers, Florida, United States
University Of Florida
Gainesville, Florida, United States
Nemours Children'S Clinic
Jacksonville, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
Nemours Childrens Hospital
Orlando, Florida, United States
All Children'S Hospital
St. Petersburg, Florida, United States
St. Joseph's Children's Hospital
Tampa, Florida, United States
St. Mary'S
West Palm Beach, Florida, United States
Children's Healthcare Of Atlanta
Atlanta, Georgia, United States
Kapiolani Medical Center For Women & Children
Honolulu, Hawaii, United States
Mountain States Tumor Institute
Boise, Idaho, United States
Ann & Robert H Lurie Children's Hospital Of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Southern Illinois University School Of Medicine
Springfield, Illinois, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, United States
Children'S Center For Cancer And Blood Diseases
Indianapolis, Indiana, United States
University Of Kentucky
Lexington, Kentucky, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Children'S Hospital Of Michigan
Detroit, Michigan, United States
Helen Devos Children'S Hospital
Grand Rapids, Michigan, United States
Michigan State University
Lansing, Michigan, United States
Childrens Hospitals And Clinics Of Minnesota
Minneapolis, Minnesota, United States
Univ Of Mississippi Med Ctr
Jackson, Mississippi, United States
University Of Missouri Health Care
Columbia, Missouri, United States
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, United States
Washington University Medical Center
St Louis, Missouri, United States
Children'S Specialty Center Of Nevada
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Goryeb Children'S Hospital
Morristown, New Jersey, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
University Of New Mexico
Albuquerque, New Mexico, United States
New York University
New York, New York, United States
The Herbert Irving Pavilion
New York, New York, United States
New York Presbyterian/Weill Cornell
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
The Children'S Medical Center Of Dayton
Dayton, Ohio, United States
The Toledo Children'S Hospital
Toledo, Ohio, United States
Mercy Children's Hospital
Toledo, Ohio, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States
Oregon Health & Sci Univ
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
East Tennessee Children'S Hosp
Knoxville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Dell Children'S Medical Center Of Central Texas
Austin, Texas, United States
Driscoll Children'S Hospital
Corpus Christi, Texas, United States
Ut Southwestern
Dallas, Texas, United States
Cook Children'S Hem/Onc Center
Fort Worth, Texas, United States
Texas Children'S Cancer Center
Houston, Texas, United States
Scott & White - McLane Children's Specialty Clinic
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Inova Pediatric Specialty Center Ii
Fairfax, Virginia, United States
Children'S Hosp-Kings Daughter
Norfolk, Virginia, United States
Seattle Children'S
Seattle, Washington, United States
St Vincent Hospital
Green Bay, Wisconsin, United States
Kenneth Desantes, Md
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution
Sth Brisbane, Queensland, Australia
Local Institution
Parkville, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Alberta Children'S Hospital
Calgary, Alberta, Canada
Stollery Children'S Hospital
Edmonton, Alberta, Canada
Local Institution
London, Ontario, Canada
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, Canada
Chu Ste-Justine
Montreal, Quebec, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Local Institution
Bologna, , Italy
Local Institution
Cagliari, , Italy
Local Institution
Catania, , Italy
Local Institution
Florence, , Italy
Local Institution
Genova, , Italy
Local Institution
Monza, , Italy
Local Institution
Napoli, , Italy
Local Institution
Palermo, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Torino, , Italy
Local Institution
Trieste, , Italy
Local Institution
San Juan, , Puerto Rico
Local Institution
Bristol, Avon, United Kingdom
Local Institution
Cardiff, Glamorgan, United Kingdom
Local Institution
Aberdeen, Grampian, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Southampton, Hampshire, United Kingdom
Local Institution
Glasgow, Lanarkshire, United Kingdom
Local Institution
Edinburgh, Lothian, United Kingdom
Local Institution
Liverpool, Merseyside, United Kingdom
Local Institution
Leeds, North Yorkshire, United Kingdom
Local Institution
Nottingham, Nottinghamshire, United Kingdom
Local Institution
Oxford, Oxfordshire, United Kingdom
Local Institution
Sheffield, South Yorkshire, United Kingdom
Local Institution
Sutton, Surrey, United Kingdom
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Local Institution
Cambridge, , United Kingdom
Countries
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References
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Hunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A. Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1.
Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2011-001123-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AALL1122
Identifier Type: OTHER
Identifier Source: secondary_id
CA180-372
Identifier Type: -
Identifier Source: org_study_id