EUCTR2007-001339-69-IT
Active, not recruiting
Not Applicable
Protocol for standardized diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia (CML). A multicenter, non-randomized, open, prospective clinical trial - CML-paed-II-Study
THE TECHNICAL UNIVERSITY OF DRESDE0 sites150 target enrollmentFebruary 6, 2008
Conditionsewly diagnosed patients with BCR-ABL-positive CMLMedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders
DrugsGLIVEC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ewly diagnosed patients with BCR-ABL-positive CML
- Sponsor
- THE TECHNICAL UNIVERSITY OF DRESDE
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Newly diagnosed Ph\+ or BCR\-ABL\-positive CML \- Male and female patients aged 0 to 18 years \- Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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