Status:
COMPLETED
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
Lead Sponsor:
University of Leipzig
Conditions:
Acute Myeloid Leukaemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Detailed Description
Measuring EFS depending on induction therapy
Eligibility Criteria
Inclusion
- Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
- written informed consent
Exclusion
- pretreatment of leukemia
- no informed consent
- simultaneous inclusion in other studies
- mental disability
- contraindication for intensive chemotherapy
- AML FAB M3
- contraindication for allogeneic stem cell transplantation
- restriction of following organ functions:
- creatinine-clearance \< 50 ml/min
- cardiac ejection fraction \< 40 %
- severe pulmonary restriction
- bilirubin \> 2x ULN; SGOT and SGPT \> 4x ULN
- uncontrolled hypertension
- severe uncontrolled metabolism disturbance
- Karnofsky-performance-score \< 70%
- hepatitis C
- other malignancy
- age of unrelated donor \>70 years and age of related donor \>75 years
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2018
Estimated Enrollment :
1222 Patients enrolled
Trial Details
Trial ID
NCT01497002
Start Date
April 1 2005
End Date
July 18 2018
Last Update
January 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Leipzig, Hematology
Leipzig, Germany, 04103