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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00003268
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed acute myeloid leukemia (AML)
* M0-M2, M4-M7
* Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood)
* M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid
* Evaluable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* SGOT/SGPT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* Ejection fraction at least 50%
* Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration
Other:
* No preexisting severe organ dysfunction
* No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study
* Not pregnant or nursing
* Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior cytotoxic therapy for AML
* No prior amifostine
* At least 1 month since chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 1 month since radiotherapy
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003268
Study Brief:
Protocol Section:
NCT00003268