Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01497002
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
* written informed consent
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01497002
Study Brief:
Protocol Section:
NCT01497002