Clinical trial NCT01460160: Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Pediatric
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Children's Oncology Group
name: EsPhALL
First posted: 2011-10-26
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Primary outcomes:
measure: 3-year Event-free Survival (EFS) Rate
timeFrame: From first dose to 3 years following first dose
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: From first dose to 100 days following last dose (up to approximately 23 months)
measure: Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
timeFrame: From first dose to 3 years or 5 years following first dose
measure: Complete Remission Rate
timeFrame: 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)
measure: Percentage of Participants Negative for Minimal Residual Disease (MRD)
timeFrame: 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)
measure: Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
timeFrame: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
state: Arizona
city: Little Rock
country: United States
facility: University Of Arkansas For Medical Sciences
state: Arkansas
city: Loma Linda
country: United States
facility: Antranik Agop Bedros
state: California
city: Long Beach
country: United States
facility: Miller Children's and Women Hospital
state: California
city: Los Angeles
country: United States
facility: Children'S Hospital Of L.A.
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Lpch & Sumc
state: California
city: Roseville
country: United States
facility: Kaiser Medical Center
state: California
city: San Francisco
country: United States
facility: Ucsf - Hematology/Oncology
state: California
city: Aurora
country: United States
facility: Children'S Hospital Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: A. I. Dupont Hospital For Children
state: Delaware
city: Washington
country: United States
facility: Children'S National Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children'S Clinic
state: Florida
city: Orlando
country: United States
facility: Md Anderson Cancer Center Orlando
state: Florida
city: Orlando
country: United States
facility: Nemours Childrens Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: All Children'S Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary'S
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare Of Atlanta
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center For Women & Children
state: Hawaii
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital Of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School Of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital For Children
state: Indiana
city: Indianapolis
country: United States
facility: Children'S Center For Cancer And Blood Diseases
state: Indiana
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Sinai Hospital Of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Children'S Hospital Of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Helen Devos Children'S Hospital
state: Michigan
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Minneapolis
country: United States
facility: Childrens Hospitals And Clinics Of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: Univ Of Mississippi Med Ctr
state: Mississippi
city: Columbia
country: United States
facility: University Of Missouri Health Care
state: Missouri
city: Kansas City
country: United States
facility: Children'S Mercy Hospital And Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Children'S Specialty Center Of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Goryeb Children'S Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: The Cancer Institute Of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University Of New Mexico
state: New Mexico
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: The Herbert Irving Pavilion
state: New York
city: New York
country: United States
facility: New York Presbyterian/Weill Cornell
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children'S Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children'S Hospital
state: Ohio
city: Dayton
country: United States
facility: The Children'S Medical Center Of Dayton
state: Ohio
city: Toledo
country: United States
facility: The Toledo Children'S Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University Of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Sci Univ
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children'S Hospital Of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital Of Pittsburgh Of UPMC
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Knoxville
country: United States
facility: East Tennessee Children'S Hosp
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Dell Children'S Medical Center Of Central Texas
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children'S Hospital
state: Texas
city: Dallas
country: United States
facility: Ut Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Cook Children'S Hem/Onc Center
state: Texas
city: Houston
country: United States
facility: Texas Children'S Cancer Center
state: Texas
city: Temple
country: United States
facility: Scott & White - McLane Children's Specialty Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Fairfax
country: United States
facility: Inova Pediatric Specialty Center Ii
state: Virginia
city: Norfolk
country: United States
facility: Children'S Hosp-Kings Daughter
state: Virginia
city: Seattle
country: United States
facility: Seattle Children'S
state: Washington
city: Green Bay
country: United States
facility: St Vincent Hospital
state: Wisconsin
city: Madison
country: United States
facility: Kenneth Desantes, Md
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Sth Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Calgary
country: Canada
facility: Alberta Children'S Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children'S Hospital
state: Alberta
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Children'S Hospital Of Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: Chu Ste-Justine
state: Quebec
city: Montreal
country: Canada
facility: The Montreal Children's Hospital of the MUHC
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Bologna
country: Italy
facility: Local Institution
city: Cagliari
country: Italy
facility: Local Institution
city: Catania
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Monza
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Palermo
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Trieste
country: Italy
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
state: Avon
city: Cardiff
country: United Kingdom
facility: Local Institution
state: Glamorgan
city: Aberdeen
country: United Kingdom
facility: Local Institution
state: Grampian
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Lothian
city: Liverpool
country: United Kingdom
facility: Local Institution
state: Merseyside
city: Leeds
country: United Kingdom
facility: Local Institution
state: North Yorkshire
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Local Institution
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Local Institution
state: South Yorkshire
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
city: Newcastle-upon-tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Cambridge
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.