CML Advocates Network

Study title

Bosutinib in Pediatric CML Patients

Scientific title

A phase I/II study of bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy (EudraCT no. 2015-002916-34)

Indication and most important inclusion criteria

Pediatric CML patients aged 1 up to 18 years 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 bone marrow, 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, 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

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
Rigshospitalet
Dr. Karsten Nysom
2100 Copenhagen

France
Institut d'hématologie et d'oncologie pédiatrique- IHOP
Dr. Yves Bertrand
69008 Lyon

Hôpital Mère-Enfant, CHU de Nantes,
Dr. Fanny Rialland
44093 Nantes Cedex 01

Germany
Universitätsklinikum Erlangen
Prof. Dr. Markus Metzler
91054 Erlangen

Ireland
Our Lady’s Children’s Hospital Crumlin
Dr. Owen Smith
Crumlin, Dublin 12

Israel
Sheba - Academic Medical Center Hospital
Dr. Bella Bielorai
Tel Hashomer, 52621

Italy
Clinica Pediatrica universita’ Milano Bicocca, Fondazione MBBM
Dr. Carmelo Rizzari
20900 Monza

Netherlands
Erasmus MC
Prof. Dr. CM Zwaan
3015GN Rotterdam

Spain
Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid

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

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

United Kingdom
The Royal Marsden NHS Foundation Trust Hospital
Dr. Donna Lancaster
Sutton, Surrey, SM2 5PT