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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00096135
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphoblastic leukemia (ALL)
* B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
* In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
* First isolated CNS and/or testicular relapse
* Isolated CNS relapse, as defined by 1 of the following:
* WBC ≥ 5/mm\^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
* Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
* Identifiable blasts AND 1 of the following:
* B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
* T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
* Isolated testicular relapse, defined as biopsy proven testicular involvement
* No Down syndrome
* No T-cell ALL or T-cell non-Hodgkin lymphoma
* No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Age
* 18 months to 29 years at relapse
Performance status
* Karnofsky 30-100% (for patients \> 16 years of age) OR
* Lansky 30-100% (for patients ≤ 16 years of age)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Creatinine adjusted according to age as follows:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\]) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
* Shortening fraction ≥ 27% by echocardiogram OR
* Ejection fraction ≥ 50% by MUGA
Other
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior bone marrow transplantation
Chemotherapy
* Prior total anthracycline dosage ≤ 360 mg/m\^2
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior systemic therapy for concurrent extramedullary relapse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
29 Years
Study:
NCT00096135
Study Brief:
Protocol Section:
NCT00096135