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

• Conditions: MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders; ewly diagnosed patients with BCR-ABL-positive CML

• Registration Number: EUCTR2007-001339-69-IT
• Lead Sponsor: THE TECHNICAL UNIVERSITY OF DRESDE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: assessment of antileukemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia;Secondary Objective: 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;Primary end point(s): Primary endpoint is the rate of hematological, cytogenetical and molecular remissions.