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:
NCT00568633
Eligibility Criteria:
INCLUSION CRITERIA
* ≥ 50 years of age and ≤ 75 years of age.
* De novo acute myelogenous leukemia (AML), based on FAB and WHO criteria.
* Intermediate or unfavorable cytogenetic abnormalities based on Southwest Oncology Group (SWOG) Cytogenetic Criteria.
* First morphologic complete remission (CR), or CRp (a complete remission but with low platelets) following 1 or 2 courses of induction therapy, documented no more than 8 weeks prior to the date of enrollment and confirmed at time of enrollment.
* Karnofsky Performance Score ≥ 60.
* Suitable for non-myeloablative transplantation or best treatment.
* Able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA
* AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria
* AML, either treatment-related or MDS-related
* Active CNS disease as identified by positive CSF cytospin at time of enrollment.
* Prior or concurrent malignancies except localized non-melanoma skin malignancies or treated cervical carcinoma in situ. (EXCEPTION: Cancer treated with curative intent \> 5 years previously is allowed. EXCEPTION: Low grade lymphoma is allowed as long as active treatment is not required for control of disease)
* Planned for allogeneic transplant using a full-dose conditioning
* Life expectancy \< 1 year due to diseases other than malignancy
* Pregnant or breastfeeding.
* HIV-seropositive.
* Uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month.
* Symptomatic coronary artery disease or uncontrolled congestive heart failure. Left ventricular ejection fraction (LVEF) is not required to be measured, however if measured, exclusion if ejection fraction is \< 30%.
* Requiring supplementary continuous oxygen. Diffusing capacity of the lungs for carbon monoxide (DLCO) is not required to be measured, however if it is measured, exclusion if DLCO \< 35%.
* Fulminant liver failure
* Cirrhosis with evidence of portal hypertension or bridging fibrosis
* Alcoholic hepatitis
* Esophageal varices
* A history of bleeding esophageal varices
* Hepatic encephalopathy
* Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
* Ascites related to portal hypertension
* Chronic viral hepatitis with total serum bilirubin \> 3 mg/dL
* Symptomatic biliary disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT00568633
Study Brief:
Protocol Section:
NCT00568633