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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00066794
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Morphologically confirmed acute myeloid leukemia (AML)
* Differential diagnosis of AML based on FAB classification system
* M0-M7 (No M3)
* No blastic transformation of chronic myelogenous leukemia
* Must be currently registered on protocols SWOG-9007 and SWOG-S9910
PATIENT CHARACTERISTICS:
Age
* 56 and over
Performance status
* Zubrod 0-3 (for patients 56 to 60 years of age) OR
* Zubrod 0-2 (for patients 61 to 70 years of age) OR
* Zubrod 0-1 (for patients 71 years of age and over)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
* AST and/or ALT no greater than 4 times ULN
Renal
* Creatinine no greater than 1.5 times ULN AND/OR
* Creatinine clearance greater than 40 mL/min
Cardiovascular
* Left ventricular function normal
* Ejection fraction at least 50% by MUGA or echocardiogram
* No unstable cardiac arrhythmias
* No unstable angina
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent pegfilgrastim
Chemotherapy
* At least 30 days since prior low-dose cytarabine (less than 100 mg/m\^2/day) for myelodysplastic syndromes and recovered
* Prior hydroxyurea to control high cell counts allowed
* No prior systemic chemotherapy for acute leukemia
* Concurrent single-dose intrathecal chemotherapy allowed
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
56 Years
Study:
NCT00066794
Study Brief:
Protocol Section:
NCT00066794