Leukemia, Pediatric Clinical Trial
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
| Verified date | November 2021 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | June 1, 2021 |
| Est. primary completion date | May 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution | Nedlands | Western Australia |
| Australia | Local Institution | Parkville | Victoria |
| Australia | Local Institution | Sth Brisbane | Queensland |
| Canada | Alberta Children'S Hospital | Calgary | Alberta |
| Canada | Stollery Children'S Hospital | Edmonton | Alberta |
| Canada | Local Institution | London | Ontario |
| Canada | Chu Ste-Justine | Montreal | Quebec |
| Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
| Canada | Children'S Hospital Of Eastern Ontario | Ottawa | Ontario |
| Canada | Local Institution | Saskatoon | Saskatchewan |
| Italy | Local Institution | Bologna | |
| Italy | Local Institution | Cagliari | |
| Italy | Local Institution | Catania | |
| Italy | Local Institution | Firenze | |
| 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 | |
| Puerto Rico | Local Institution | San Juan | |
| United Kingdom | Local Institution | Aberdeen | Grampian |
| United Kingdom | Local Institution | Birmingham | West Midlands |
| United Kingdom | Local Institution | Bristol | Avon |
| United Kingdom | Local Institution | Cambridge | |
| United Kingdom | Local Institution | Cardiff | Glamorgan |
| United Kingdom | Local Institution | Edinburgh | Lothian |
| United Kingdom | Local Institution | Glasgow | Lanarkshire |
| United Kingdom | Local Institution | Leeds | North Yorkshire |
| United Kingdom | Local Institution | Liverpool | Merseyside |
| United Kingdom | Local Institution | London | Greater London |
| United Kingdom | Local Institution | Manchester | Greater Manchester |
| United Kingdom | Local Institution | Newcastle-upon-tyne | Tyne And Wear |
| United Kingdom | Local Institution | Nottingham | Nottinghamshire |
| United Kingdom | Local Institution | Oxford | Oxfordshire |
| United Kingdom | Local Institution | Sheffield | South Yorkshire |
| United Kingdom | Local Institution | Southampton | Hampshire |
| United Kingdom | Local Institution | Sutton | Surrey |
| United States | University Of New Mexico | Albuquerque | New Mexico |
| United States | Children's Healthcare Of Atlanta | Atlanta | Georgia |
| United States | Children'S Hospital Colorado | Aurora | Colorado |
| United States | Dell Children'S Medical Center Of Central Texas | Austin | Texas |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Sinai Hospital Of Baltimore | Baltimore | Maryland |
| United States | University Of Alabama At Birmingham | Birmingham | Alabama |
| United States | Mountain States Tumor Institute | Boise | Idaho |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Levine Children's Hospital | Charlotte | North Carolina |
| United States | Ann & Robert H Lurie Children's Hospital Of Chicago | Chicago | Illinois |
| United States | Cincinnati Children'S Hospital Medical Center | Cincinnati | Ohio |
| United States | University Of Missouri Health Care | Columbia | Missouri |
| United States | Nationwide Children'S Hospital | Columbus | Ohio |
| United States | Driscoll Children'S Hospital | Corpus Christi | Texas |
| United States | Ut Southwestern | Dallas | Texas |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | The Children'S Medical Center Of Dayton | Dayton | Ohio |
| United States | Children'S Hospital Of Michigan | Detroit | Michigan |
| United States | Inova Pediatric Specialty Center Ii | Fairfax | Virginia |
| United States | Lee Memorial Health System | Fort Myers | Florida |
| United States | Cook Children'S Hem/Onc Center | Fort Worth | Texas |
| United States | University Of Florida | Gainesville | Florida |
| United States | Helen Devos Children'S Hospital | Grand Rapids | Michigan |
| United States | St Vincent Hospital | Green Bay | Wisconsin |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Connecticut Children's Medical Center | Hartford | Connecticut |
| United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
| United States | Kapiolani Medical Center For Women & Children | Honolulu | Hawaii |
| United States | Texas Children'S Cancer Center | Houston | Texas |
| United States | Children'S Center For Cancer And Blood Diseases | Indianapolis | Indiana |
| United States | James Whitcomb Riley Hospital For Children | Indianapolis | Indiana |
| United States | Univ Of Mississippi Med Ctr | Jackson | Mississippi |
| United States | Nemours Children'S Clinic | Jacksonville | Florida |
| United States | Children'S Mercy Hospital And Clinics | Kansas City | Missouri |
| United States | East Tennessee Children'S Hosp | Knoxville | Tennessee |
| United States | Michigan State University | Lansing | Michigan |
| United States | Children'S Specialty Center Of Nevada | Las Vegas | Nevada |
| United States | University Of Kentucky | Lexington | Kentucky |
| 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 | Norton Children's Hospital | Louisville | Kentucky |
| United States | Valley Children's Hospital | Madera | California |
| United States | Kenneth Desantes, Md | Madison | Wisconsin |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Childrens Hospitals And Clinics Of Minnesota | Minneapolis | Minnesota |
| United States | Goryeb Children'S Hospital | Morristown | New Jersey |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | The Cancer Institute Of New Jersey | New Brunswick | New Jersey |
| United States | New York Presbyterian/Weill Cornell | New York | New York |
| United States | New York University | New York | New York |
| United States | The Herbert Irving Pavilion | New York | New York |
| United States | Newark Beth Israel Medical Center | Newark | New Jersey |
| United States | Children'S Hosp-Kings Daughter | Norfolk | Virginia |
| United States | University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Md Anderson Cancer Center Orlando | Orlando | Florida |
| United States | Nemours Childrens Hospital | Orlando | Florida |
| United States | Lpch & Sumc | Palo Alto | California |
| United States | St. Joseph's Regional Medical Center | Paterson | New Jersey |
| United States | Children'S Hospital Of Philadelphia | Philadelphia | Pennsylvania |
| United States | Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. | Phoenix | Arizona |
| United States | Children's Hospital Of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania |
| United States | Legacy Emanuel Hospital & Health Center | Portland | Oregon |
| United States | Oregon Health & Sci Univ | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Kaiser Medical Center | Roseville | California |
| United States | Washington University Medical Center | Saint Louis | Missouri |
| United States | All Children'S Hospital | Saint Petersburg | Florida |
| United States | Primary Children's Medical Center | Salt Lake City | Utah |
| United States | Ucsf - Hematology/Oncology | San Francisco | California |
| United States | Seattle Children'S | Seattle | Washington |
| United States | Southern Illinois University School Of Medicine | Springfield | Illinois |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | St. Joseph's Children's Hospital | Tampa | Florida |
| United States | Scott & White - McLane Children's Specialty Clinic | Temple | Texas |
| United States | Mercy Children's Hospital | Toledo | Ohio |
| United States | The Toledo Children'S Hospital | Toledo | Ohio |
| United States | New York Medical College | Valhalla | New York |
| United States | Children'S National Medical Center | Washington | District of Columbia |
| United States | St. Mary'S | West Palm Beach | Florida |
| United States | A. I. Dupont Hospital For Children | Wilmington | Delaware |
| United States | Wake Forest University | Winston-Salem | North Carolina |
| United States | UMass Memorial Medical Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Children's Oncology Group, EsPhALL |
United States, Australia, Canada, Italy, Puerto Rico, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of all causality all grade adverse events | From first dose to 100 days following last dose (up to approximately 23 months) | |
| Secondary | Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | 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. | From first dose to 3 years or 5 years following first dose | |
| Secondary | Complete Remission Rate | 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. | 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) | |
| Secondary | Percentage of Participants Negative for Minimal Residual Disease (MRD) | 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% | 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) | |
| Secondary | Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse | 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. | At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) |