CML-paed II Registry

Author:  Julia Dobke, Last modification: 2024/10/29 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 and treated at GPOH centres (see list) according to the current guidelines. Treatment is carried out within the framework of the approval with both imatinib and the second-generation tyrosine kinase inhibitors, dasatinib and nilotinib, which meanwhile have been approved as well. The agents are not given as part of the study. Patients are treated independently of the registry (already before and after). No disadvantages for current and future therapies are associated with the registry.

Therapy / Study arms
  • CML-paed registry: prospective, multicentre, GPOH centres
  • Since 01/01/2016, the registry has been sequel to a therapy optimising trial closed by 31/12/2015 (end of follow-up by the end of 2020). Since the change of trial coordination on 01/04/2018, the trial centre has been located in Erlangen.
  • 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
  • 18 years of age and older
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