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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00209833
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
* diagnosis of secondary AML after chemo-/radiotherapy or MDS
* diagnosis of RAEB-T
* age between 16 and 60 years (including 60 years)
* women after exclusion of pregnancy
* written informed consent
Exclusion Criteria:
* patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
* patients with DLCO \< 50%
* patients with creatinine clearance \< 60 ml/min
* patients with bilirubin \> 2mg% (34.2 mmol/L)
* patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
* patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
* HIV positivity
* patients with a t(15;17) translocation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00209833
Study Brief:
Protocol Section:
NCT00209833