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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT00005793
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed, previously untreated acute myeloid leukemia (AML)
* All FAB types, M0-M7, excluding M3
* No AML after myelodysplastic syndrome
PATIENT CHARACTERISTICS:
Age:
* 16 to 59
Performance status:
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2 mg/dL
* SGOT/SGPT normal unless due to leukemic disease
* Alkaline phosphatase normal unless due to leukemic disease
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Ejection fraction at least 50% by MUGA
* No myocardial infarction or serious ventricular arrhythmia within the past 6 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except resected skin cancer
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior topotecan or any other DNA topoisomerase I inhibitor (e.g., irinotecan, aminocamptothecin, or nitrocamptothecin) or etoposide for any prior malignancy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
59 Years
Study:
NCT00005793
Study Brief:
Protocol Section:
NCT00005793