Status:
UNKNOWN
Registration of Children With CML and Treatment With Imatinib
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Medical Academy of Wroclaw, Poland
University of Leiden, Netherlands
Conditions:
Myeloid Leukemia, Chronic
Eligibility:
All Genders
1-18 years
Brief Summary
Newly diagnosed pediatric patients (age \< 19 years) with bcr-abl-positive CML will be treated with imatinib. Serial monitoring of treatment response is performed in one month intervals during the fir...
Detailed Description
Indication: Newly diagnosed pediatric patients with bcr-abl-positive CML. Design: Multicenter, non-randomized, open, prospective clinical trial. Objectives: Primary: \- assessment of antileukemi...
Eligibility Criteria
Inclusion
- Newly diagnosed Ph+ or bcr-abl-positive CML
- Male and female patients aged 0 to 18 years
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00445822
Start Date
March 1 2007
End Date
December 1 2012
Last Update
February 29 2012
Active Locations (1)
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1
University Children's Hopsital, Technical University of Dresden, Fetscherstr. 74
Dresden, Saxony, Germany, D-01307