CML Advocates Network

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 COG (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

Spain

Madrid:
Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid

Switzerland

Zurich:
Universitäts-Kinderspital Zürich
Dr. J.P. Bourquin
8032 Zurich

The Netherlands

Utrecht:
Princess Maxima center for pediatric oncology
Dr. Inge van der Sluis
3584 CS Utrecht

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