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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00003602
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed de novo or secondary acute myeloid leukemia (AML)
* Prior myelodysplasia allowed
* Refractory anemia with excess blasts (RAEB) OR
* RAEB in transformation
* No relapsed AML
* No chronic granulocytic leukemia in transformation
* No CNS disease
PATIENT CHARACTERISTICS:
Age:
* Over 55
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 2.5 times ULN
Cardiovascular:
* No severe or uncontrolled cardiac failure
Other:
* No serious medical, social, or psychological condition
* Not HIV 1 or 2 seropositive
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No plan for future autograft
Chemotherapy:
* No prior chemotherapy for myelodysplastic syndrome or AML
Endocrine therapy:
* Not specifed
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent aluminum or magnesium-based antacids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00003602
Study Brief:
Protocol Section:
NCT00003602