Curative and palliative treatment of adults aged > 60 years with AML.A randomised trial by OSHO on the role of (1) early intensification {OSHO protocol} vs. common standard arm of German AML Intergroup Study, (2) allografting as consolidative immunotherapy vs. a second consolidation course in elderly patients,(3) prospective evaluation of the decision between curative and palliative treatment-intention. - AML 2004 OSHO #069
- Conditions
- Acute myelogenous leukemia
- Registration Number
- EUCTR2005-002833-10-AT
- Lead Sponsor
- German Competence network Acute and Chronic Leukemias” sponsored by Federal Ministry of Education a
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
AML according to the WHO classification (1999)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Acute promyelocytic leukemie (APL; t(15;17))
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Comparison of EFS of OSHO arm versus standard arm of German AML Intergroup Study<br>2. Comparison of LFS and OS after allogeneic transplantation given as second consolidation versus a second chemotherapy consolidation course;Secondary Objective: ;Primary end point(s): Event free survival
- Secondary Outcome Measures
Name Time Method