Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
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
3 other identifiers
interventional
106
6 countries
128
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
Longer than P75 for phase_2
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedStudy Start
First participant enrolled
April 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2017
CompletedResults Posted
Study results publicly available
August 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedDecember 8, 2021
November 1, 2021
5.1 years
October 25, 2011
May 25, 2018
November 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
3-year Event-free Survival (EFS) Rate
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
From first dose to 3 years following first dose
Secondary Outcomes (5)
Number of Participants Experiencing Adverse Events
From first dose to 100 days following last dose (up to approximately 23 months)
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
From first dose to 3 years or 5 years following first dose
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)
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)
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)
Study Arms (1)
Arm 1: Dasatinib
EXPERIMENTALInterventions
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
- Extramedullary involvement of the testicles
- Active systemic bacterial, fungal or viral infection
- Down syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Children's Oncology Groupcollaborator
- EsPhALLcollaborator
Study Sites (128)
University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix, Arizona, 85016, United States
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, 72202, United States
Antranik Agop Bedros
Loma Linda, California, 92350, United States
Miller Children's and Women Hospital
Long Beach, California, 90806, United States
Children'S Hospital Of L.A.
Los Angeles, California, 90027, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Valley Children's Hospital
Madera, California, 93636, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lpch & Sumc
Palo Alto, California, 94304, United States
Kaiser Medical Center
Roseville, California, 95661, United States
Ucsf - Hematology/Oncology
San Francisco, California, 94143-0106, United States
Children'S Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
A. I. Dupont Hospital For Children
Wilmington, Delaware, 19803, United States
Children'S National Medical Center
Washington D.C., District of Columbia, 20010, United States
Lee Memorial Health System
Fort Myers, Florida, 33908, United States
University Of Florida
Gainesville, Florida, 32610, United States
Nemours Children'S Clinic
Jacksonville, Florida, 32207, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Nemours Childrens Hospital
Orlando, Florida, 32827, United States
All Children'S Hospital
St. Petersburg, Florida, 33629, United States
St. Joseph's Children's Hospital
Tampa, Florida, 33607, United States
St. Mary'S
West Palm Beach, Florida, 33407, United States
Children's Healthcare Of Atlanta
Atlanta, Georgia, 30322, United States
Kapiolani Medical Center For Women & Children
Honolulu, Hawaii, 96826, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Ann & Robert H Lurie Children's Hospital Of Chicago
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Southern Illinois University School Of Medicine
Springfield, Illinois, 62794-9635, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, 46202-5225, United States
Children'S Center For Cancer And Blood Diseases
Indianapolis, Indiana, 46260, United States
University Of Kentucky
Lexington, Kentucky, 40536-0284, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Children'S Hospital Of Michigan
Detroit, Michigan, 48201, United States
Helen Devos Children'S Hospital
Grand Rapids, Michigan, 49503, United States
Michigan State University
Lansing, Michigan, 48912, United States
Childrens Hospitals And Clinics Of Minnesota
Minneapolis, Minnesota, 55404, United States
Univ Of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
University Of Missouri Health Care
Columbia, Missouri, 65212, United States
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, 64108, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Children'S Specialty Center Of Nevada
Las Vegas, Nevada, 89109, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Goryeb Children'S Hospital
Morristown, New Jersey, 07962, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
University Of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
New York University
New York, New York, 10016, United States
The Herbert Irving Pavilion
New York, New York, 10032, United States
New York Presbyterian/Weill Cornell
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
New York Medical College
Valhalla, New York, 10595, United States
Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Wake Forest University
Winston-Salem, North Carolina, 27157-1081, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Nationwide Children'S Hospital
Columbus, Ohio, 43205, United States
The Children'S Medical Center Of Dayton
Dayton, Ohio, 45404-1815, United States
The Toledo Children'S Hospital
Toledo, Ohio, 43606, United States
Mercy Children's Hospital
Toledo, Ohio, 43608, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97227, United States
Oregon Health & Sci Univ
Portland, Oregon, 97239, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-1320, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104-4318, United States
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
East Tennessee Children'S Hosp
Knoxville, Tennessee, 37916, United States
Vanderbilt University
Nashville, Tennessee, 37232-6310, United States
Dell Children'S Medical Center Of Central Texas
Austin, Texas, 78723, United States
Driscoll Children'S Hospital
Corpus Christi, Texas, 78411, United States
Ut Southwestern
Dallas, Texas, 75390-9063, United States
Cook Children'S Hem/Onc Center
Fort Worth, Texas, 76104, United States
Texas Children'S Cancer Center
Houston, Texas, 77030, United States
Scott & White - McLane Children's Specialty Clinic
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Inova Pediatric Specialty Center Ii
Fairfax, Virginia, 22031, United States
Children'S Hosp-Kings Daughter
Norfolk, Virginia, 23507, United States
Seattle Children'S
Seattle, Washington, 98105, United States
St Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Kenneth Desantes, Md
Madison, Wisconsin, 53705-2275, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Local Institution
Sth Brisbane, Queensland, 4101, Australia
Local Institution
Parkville, Victoria, 3052, Australia
Local Institution
Nedlands, Western Australia, 6009, Australia
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8, Canada
Stollery Children'S Hospital
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
London, Ontario, N6A 5W9, Canada
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Chu Ste-Justine
Montreal, Quebec, H3T 1C5, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H4A 3J1, Canada
Local Institution
Saskatoon, Saskatchewan, S7N 4H4, Canada
Local Institution
Bologna, 40138, Italy
Local Institution
Cagliari, 09121, Italy
Local Institution
Catania, 95123, Italy
Local Institution
Florence, 50139, Italy
Local Institution
Genova, 16147, Italy
Local Institution
Monza, 20900, Italy
Local Institution
Napoli, 80123, Italy
Local Institution
Palermo, 90134, Italy
Local Institution
Roma, 00161, Italy
Local Institution
Roma, 00165, Italy
Local Institution
Torino, 10126, Italy
Local Institution
Trieste, 34137, Italy
Local Institution
San Juan, 00912, Puerto Rico
Local Institution
Bristol, Avon, BS2 8BJ, United Kingdom
Local Institution
Cardiff, Glamorgan, CF14 4XW, United Kingdom
Local Institution
Aberdeen, Grampian, AB25 2ZG, United Kingdom
Local Institution
London, Greater London, WC1N3JH, United Kingdom
Local Institution
Manchester, Greater Manchester, M27 4HA, United Kingdom
Local Institution
Southampton, Hampshire, SO9 4XY, United Kingdom
Local Institution
Glasgow, Lanarkshire, G3 8SJ, United Kingdom
Local Institution
Edinburgh, Lothian, EH9 1LF, United Kingdom
Local Institution
Liverpool, Merseyside, L12 2AP, United Kingdom
Local Institution
Leeds, North Yorkshire, LS1 3EX, United Kingdom
Local Institution
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Local Institution
Oxford, Oxfordshire, OX 39DU, United Kingdom
Local Institution
Sheffield, South Yorkshire, S10 2TH, United Kingdom
Local Institution
Sutton, Surrey, SM2 5PT, United Kingdom
Local Institution
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
Local Institution
Birmingham, West Midlands, B4 6NH, United Kingdom
Local Institution
Cambridge, CB2 2QQ, United Kingdom
Related Publications (2)
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.
PMID: 37407142DERIVEDTasian 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.
PMID: 33242441DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2011
First Posted
October 26, 2011
Study Start
April 13, 2012
Primary Completion
May 28, 2017
Study Completion
June 1, 2021
Last Updated
December 8, 2021
Results First Posted
August 21, 2018
Record last verified: 2021-11