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Clinical Trials/EUCTR2007-001339-69-IT
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

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.

Registry
who.int
Start Date
February 6, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
THE TECHNICAL UNIVERSITY OF DRESDE

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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