CML-Paed II = Registration of Children with CML and Treatment with Imatinib [Germany]
Study title
CML-Paed II = Registration of Children awith CML and Treatment with Imatinib
Scientific title
Protocol for standardized diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia (CML) (EudraCT 2007-001339-69, ClinicalTrials.gov NCT00445822)
Type of study
Paediatric trial
Current status
No longer recruiting
What is the purpose of the study
The objective of this study is to assess the antileukemic activity of imatinib in children and adolescents with newly diagnosed Ph+ or BCR-ABL-CML over a treatment period of two years. Primary endpoint is the rate of haematological, cytogenetical and molecular remissions.
Key inclusion criteria
Newly diagnosed Ph+ or BCR-ABL-positive CML in children and adolescents under the age of 18 years. Potential study participants have not been pretreated with interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for the treatment of CML). However, these patients may be registered as observational patients.
Key exclusion criteria
Where can I find additional information
Study sponsor
Universität Dresden, Germany
Scientific lead / contact
Prof. Dr. Meinolf Suttorp
Principal investigator
Prof. Dr. Meinolf Suttorp
Universitätsklinikum Dresden
Bereich pädiatrische Hämatologie und Onkologie
Study centers / principal investigators
Centers of paediatric haematology oncology within the network of the Society for Paediatric Oncology and Haematology (GPOH) or of the national societies of Paediatric Oncology and Haematology