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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT00002693
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories:
* Failed to achieve a complete response (CR) with initial induction regimen
* First relapse within 1 year of initial CR
* Failed re-induction therapy at first relapse
* Second relapse after no more than 2 different induction regimens
* Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either:
* Symptoms of recurrence (e.g., B symptoms)
* Evidence of impending marrow failure (i.e., cytopenias) OR
* Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen
* No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation
* No clinical symptoms of CNS leukemia
* Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease
* No active CNS disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 4 weeks
Hematologic:
* Not applicable
Hepatic:
* Bilirubin less than 2 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No congestive heart failure
* No poorly controlled arrhythmia
* No myocardial infarction within the past 3 months
Other:
* No active infection
* No other serious medical condition that would prevent compliance
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 24 hours since prior hydroxyurea for impending leukostasis
* No concurrent hydroxyurea glucocorticoids
* Recovered from prior chemotherapy
Endocrine therapy:
* At least 24 hours since prior glucocorticoids for impending leukostasis
* At least 7 days since prior amphotericin or aminoglycosides
* No concurrent glucocorticoids
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent aminoglycoside antibiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002693
Study Brief:
Protocol Section:
NCT00002693