CML-paed II Registry

Author:  Julia Dobke, Last modification: 2024/07/22 https://kinderkrebsinfo.de/doi/e231347

CML-paed II Registry

Protocol for standardised diagnostical procedures, registration und treatment recommendations for children and adolescents with Philadelphia- positive chronic myeloid leukaemia
Disease

Chronic myeloid leukaemia (CML)
Type

Prospective registry
Rationale / Objectives

The patients are usually diagnosed at the GPOH centers (see list) according to guidelines and treated. The treatment takes place within the framework of the approval for both imatinib and in the meantime approved second-generation tyrosine kinase inhibitors dasatinib and nilotinib. The Medicines are not given for study reasons. The patients are independent of the registry in Treatment (already before and after). The register also does not result in any disadvantages for current and future therapies.
Therapy / Study arms
  • CML-paed registry: prospective, multicentric, GPOH centers
  • Follow-up of a multi-center, non-randomized, open-label, prospective study that closed on 31.12.2025. Continuation as a registry in with change of management starting April 1st, 2018 to Erlangen (Prof. Dr. med. M. Metzler).
  • Follow-up of the study patients until the end of 2020.
  • Registration of new patients from 01.01.2016
  • Study Arms: None
Inclusion Criteria
  • newly diagnosed Ph+ or BCR-ABL-positive CML
  • male oder female patients from age 0 to 17
  • written informed consent
Exclusion Criteria
  • Age > 18 years
Recruitment unlimited
Status 01.01.2016 - until further notice
Principal Investigator Prof. Dr. med. M. Metzler
E-Mail cml-paed@uk-erlangen.de
URL https://www.kinderonkologie.uk-erlangen.de/forschung-und-lehre/cml-studie/formulare-und-downloads/
Contact

Coordinator

Prof. Dr. med. Markus Metzler Universitätsklinikum Erlangen Kinder- und Jugendklinik Loschgestr. 15 91054 Erlangen Telefon +49(0) 9131 85-33731 Fax +49(0) 9131 85-35742 cml-paed@uk-erlangen.de

Participants GPOH centres