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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00091234
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed acute myeloid leukemia (AML)
* At least 20% bone marrow blasts by bone marrow aspiration or biopsy
* All subtypes except M3 (acute promyelocytic leukemia) are allowed
* Previously untreated primary or secondary disease (including AML after myelodysplastic syndromes)
* Ineligible for intensive chemotherapy, as defined by 1 of the following criteria:
* 61 to 75 years old AND WHO performance status \> 2 AND/OR unwilling to receive intensive chemotherapy
* Over 75 years old
* No blast crisis of chronic myeloid leukemia
* No AML supervention after other myeloproliferative disease
* WBC \< 30,000/mm\^3 and meets 1 of the following criteria:
* WBC \< 30,000/mm\^3 at diagnosis AND had no prior treatment with hydroxyurea
* WBC ≥ 30,000/mm\^3 at diagnosis AND received mandatory pretreatment with hydroxyurea (up to 14 days duration) until WBC \< 30,000/mm\^3
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
* See Disease Characteristics
* 61 and over
Performance status
* See Disease Characteristics
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No arrhythmia requiring chronic treatment
* No congestive heart failure
* No symptomatic ischemic heart disease
* No other severe cardiovascular disease
Pulmonary
* No severe pulmonary dysfunction ≥ grade 3
Other
* No alcohol abuse
* No severe neurological or psychiatric disease
* No active uncontrolled infection or severe systemic infection
* No other malignancy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* No concurrent antiangiogenic drugs
Chemotherapy
* See Disease Characteristics
* Concurrent low-dose cytostatic agents (i.e., thioguanine or mercaptopurine) allowed for palliative care (standard supportive care arm only)
Endocrine therapy
* Prior corticosteroids (duration ≤ 14 days ) for primary or secondary AML allowed
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No other concurrent cytotoxic drugs
* No other concurrent experimental therapy
* No concurrent tyrosine kinase inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
61 Years
Study:
NCT00091234
Study Brief:
Protocol Section:
NCT00091234