Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Newly diagnosed pediatric patients with bcr-abl-positive CML.
Multicenter, non-randomized, open, prospective clinical trial.
- assessment of antileukemic activity of imatinib in children and adolescents with
Philadelphia chromosome-positive chronic myeloid leukemia
- assessment of the time-to event-efficacy variables
- correlation of the quality of haematological, cytogenetical and molecular remission in
children and adolescents with CML on ongoing imatinib therapy with survival
- safety of imatinib
- rate of haematological, cytogenetical and molecular remissions
- time to progression
- duration of chronic phase
- time to loss of response
- overall survival
- assessment of treatment-related toxicities in children and adolescents.
Newly diagnosed Ph+ or bcr-abl-positive CML- Male and female patients aged 0 to 18 years-
Written informed consent
- CML without bcr-abl rearrangement detectable by PCR
- Pretreatment with Interferon alpha or any other cytostatic drug with the exception of
hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of
CML). However, these patients may be registered as observational patients.
- Any other severe underlying disease beside CML.
- Age > 18 years
- Pregnant or lactating women
- Subjects unlikely to comply with the requirements of the protocol
Number of patients to be enrolled: 150
Recruitment period: 5 years
Treatment period: 2 years
Planned start of study: 2007
Planned end of study: 2013
Observational Model: Cohort, Time Perspective: Prospective
Meinolf Suttorp, Prof. Dr.
University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany
Germany: Ethics Commission