BCHILD - Bosutinib in Pediatric Patients [Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, UK, USA]
Study title
Bosutinib in Pediatric CML Patients (ITCC-054/COG AAML1921)
Scientific title
A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia,
study ITCC-054/COG AAML1921 (ClinicalTrials.gov NCT04258943; EudraCT no. 2015-002916-34)
Indication and most important inclusion criteria
Pediatric CML patients aged 1 up to 18 years with newly diagnosed chronic phase CML, or patients who are resistant (suboptimal response or failure, as defined by 2013 European Leukemia Net guidelines) or intolerant (with or without suboptimal response or failure) to at least one prior tyrosine kinase inhibitor (TKI).
To be included, patients need to have adequate renal, liver and heart function as well as a Lansky performance status of at least 50% for patients up to 16 years of age, or a Karnofsky scale of at least 50% for patients over 16 years of age. Lansky performance status and Karnofsky scale are used to assess to what extent patients are able to carry on normal activities.
Short description of intervention
In this dose-finding study, the recommended dose of bosutinib will be determined based on the safety and tolerability profile of bosutinib.
Type of study
Pediatric trial
Current status
Recruiting
Study sponsor
Erasmus Medical Centre, Rotterdam, and Children's Oncology Group (for USA sites) with support from Pfizer
Scientific lead / contact
Prof. Dr. CM Zwaan
Erasmus Medical Centre
Rotterdam, Netherlands
Principal investigator
Prof. Dr. CM Zwaan
Erasmus Medical Centre
Rotterdam, Netherlands
For USA:
Dr. Hijiya
Columbia University Irving Medical Center
New York, N.Y.
Additional information
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study description in the Nederlands Trials Register
Study centers / principal investigators
Denmark
Copenhagen:
Rigshospitalet
Dr. Karsten Nysom
2100 Copenhagen
France
Lyon:
Institut d'hématologie et d'oncologie pédiatrique- IHOP
Dr. Yves Bertrand
69008 Lyon
Nantes:
Hôpital Mère-Enfant, CHU de Nantes,
Dr. Fanny Rialland
44093 Nantes Cedex 01
Paris:
Hôpital Armand Trousseau
Dr. Petit
75012 Paris
Hôpital Robert Debré
Dr. Brethon
75019 Paris
Germany
Erlangen:
Universitätsklinikum Erlangen
Prof. Dr. Markus Metzler
91054 Erlangen
Essen:
Universitätsklinikum Essen
Dr. Reinhardt
Hufelandstrasse 55
45147 Essen
Ireland
Dublin:
Our Lady’s Children’s Hospital Crumlin
Dr. Owen Smith
Crumlin, Dublin 12
Israel
Tel Hashomer:
Sheba - Academic Medical Center Hospital
Dr. Bella Bielorai
Tel Hashomer, 52621
Italy
Monza:
Clinica Pediatrica universita’ Milano Bicocca, Fondazione MBBM
Dr. Carmelo Rizzari
20900 Monza
Rome:
Ospedale pediatrico bambino gesu’
Dr. Locatelli
Piazza S.Onofrio, 4, Rome
Torino:
Regina Margherita Children’s Hospital
Dr. Bertorello
Piazza Polonia 94, 10126 Torino
Netherlands
Rotterdam:
Erasmus MC
Prof. Dr. CM Zwaan
3015GN Rotterdam
Utrecht:
Princess Maxima center for pediatric oncology
Dr. Inge van der Sluis
3584 CS Utrecht
Spain
Barcelona:
Hospital Universitari Vall d’Hebron
Dr. P. Velasco
08035 Barcelona
Madrid:
Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid
Switzerland
Zurich:
Universitäts-Kinderspital Zürich
Dr. J.P. Bourquin
8032 Zurich
United Kingdom
Birmingham:
Birmingham Children’s Hospital
Dr. Motwani
Steelhouse Lane, Birmingham, B4 6NH
Sutton:
The Royal Marsden NHS Foundation Trust Hospital
Dr. Donna Lancaster
Sutton, Surrey, SM2 5PT
United States
Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Principal Investigator: David Becton, MD
California
Loma Linda University Medical Center
Loma Linda, California, 92354
Principal Investigator: Albert Kheradpour, MD
Kaiser Permanente-Oakland
Oakland, California, 94611
Principal investigator: Laura Campbell
Children's Hospital of Orange County
Orange, California, 92868
Principal investigator: Jamie Frediani
Florida
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Principal Investigator: William Slayton
Nemours Children's Hospital
Orlando, Florida, 32827
Principal Investigator: Ramamoorthy Nagasubramanian, MD
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Principal Investigator: Wade T. Kyono
Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Principal Investigator: Keith August, MD MSc
Nevada
Children's Specialty Center of Nevada II
Las Vegas, Nevada, 89109
Principal Investigator: Alan Ikeda
New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Principal Investigator: Richard A. Drachtman, MD
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator: Robin Norris, MD MPH
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Principal Investigator: Andrew Bukowinski, MD
Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Principal Investigator: Shannon Cohn, MD
UT Southwestern Medical Center Simmons Cancer Center
Dallas, Texas, 75235-9063
Principal investigator: Tamra Slone
Virginia
Children's Hospital of Kings Daughters
Norfolk, Virginia, 23507
Principal investigator: Eric Lowe