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:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00121303
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia (AML)
* M0-M2 or M4-M7 FAB subtype
* No AML with cytogenetic abnormality t(15;17) (M3)
* Patients with secondary AML progressing from prior myelodysplasia\* or biphenotypic leukemia are eligible
* Refractory anemia with excess blasts (RAEB) or RAEB in transformation
* International Prognostic Scoring System score ≥ 1.5 NOTE: \*Any prior hematological disease of ≥ 4 months duration
* No chronic myelogenous leukemia in blastic crisis
* No prior polycythemia rubra vera
* No primary myelofibrosis
PATIENT CHARACTERISTICS:
Age
* 61 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)\*
* Bilirubin ≤ 2 times ULN\* NOTE: \*Unless elevation is caused by organ infiltration by AML
Renal
* Creatinine ≤ 2 times ULN\* NOTE: \*Unless elevation is caused by organ infiltration by AML
Cardiovascular
* No myocardial infarction within the past 6 months
* LVEF \> 50% by MUGA, echocardiogram, or other methods
* No unstable angina
* No unstable cardiac arrhythmia
* No severe and/or uncontrolled hypertension
Other
* No uncontrolled diabetes
* No severe and/or uncontrolled infection
* No other severe and/or uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 6 months since prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior induction therapy for AML or myelodysplastic syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
61 Years
Maximum Age:
120 Years
Study:
NCT00121303
Study Brief:
Protocol Section:
NCT00121303