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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00002704
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Acute lymphoblastic leukemia in first bone marrow remission (M1) with first isolated initial CNS relapse
* More than 5 WBC/microliter in cerebrospinal fluid (CSF) with blasts on cytospin OR immunophenotypic proof (encouraged) of relapse in CSF
* Identifiable blasts and presence on 2 CSF samples 3 weeks apart
* If B-cell terminal deoxynucleotidyl transferase (TdT) OR CD-10
* If T-cell TdT alone OR with CD-7
PATIENT CHARACTERISTICS:
* Age: Over 6 months and under 21 years at relapse
* Patients receiving sustained release cytarabine
* Performance status: Older than 10 years
* Karnofsky greater than 50% Less than 10 years
* Lansky greater than 50%
* Platelet count greater than 40,000/mm3
* Bilirubin less than 2.0 mg/dL
* SGPT less than 5 times normal
* Creatinine less than 1.5 times normal for age
* Normal metabolic parameters (serum electrolytes, calcium, and phosphorus)
* No clinical evidence of obstructive hydrocephalus, compartmentalization of the CSF flow, ventriculoperitoneal or ventriculoatrial shunt
PRIOR CONCURRENT THERAPY:
* Prior cumulative anthracycline dose less than 375 mg/sqm
* Patients receiving sustained release cytarabine
* At least 7 days since prior investigational drug
* At least 3 weeks since prior CNS directed therapy (6 weeks is prior nitrosourea)
* At least 1 week since intrathecal chemotherapy
* At least 8 weeks since prior craniospinal radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
20 Years
Study:
NCT00002704
Study Brief:
Protocol Section:
NCT00002704