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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00002912
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Acute myeloid leukemia (AML) in one of the following categories:
* First relapse if initial CR less than 6 months
* Refractory to first or second induction with daunomycin, cytarabine, and thioguanine (DAT) or other anthracycline-containing regimens
* Relapse following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant
* Presentation with secondary AML or AML evolving from myelodysplastic syndrome --Acute lymphocytic leukemia in one of the following categories:
* In second or subsequent relapse or failed second or later induction attempts regardless of prior remissions
* Relapsed following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant
* No isolated CNS or extramedullary relapse
PATIENT CHARACTERISTICS:
* Age: Under 22 at diagnosis
* Performance status: Karnofsky 50-100% (ECOG 0-2)
* Lansky 40-100% (in patients under 12 years of age)
* Life expectancy: At least 8 weeks
* Bilirubin less than 1.5 mg/dL
* ALT less than twice normal
* Creatinine normal for age (within 2 standard deviations) OR glomular filtration rate at least 70 mL/min
* Albumin at least 3 g/dL
* Ejection fraction greater than 50% at rest or with 5% increase with exercise OR shortening fraction greater than 27% by echocardiogram
* No history of clinical heart failure
* No uncontrolled infection
* No anticonvulsant therapy
* No history of allergic reactions or anaphylaxis to etoposide not remediable by premedication
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Third percentile weight for height
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since chemotherapy and recovered
* Prior cumulative anthracycline dose no greater than 360 mg per square meter
* Hydroxyurea therapy allowed just prior to study for rapidly rising blast count
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00002912
Study Brief:
Protocol Section:
NCT00002912