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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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Paediatric trial

Current status

No longer recruiting

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

Additional information

Study description in ClinicalTrials.gov

Study protocol in English, Patient information in Germany, Fachinformation Glivec in German