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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00003528
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
* No CNS leukemia
* No solid tumors
* Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
* Life expectancy: At least 8 weeks
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times normal
* Normal creatinine for age OR GFR at least 70 mL/min
* No significant systemic illness such as infection
* No significant third space fluid collection
* Not pregnant or nursing
* Recovered from acute toxic effects of prior immunotherapy
* At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
* At least 10 days since prior biologic therapy
* At least 1 week since prior growth factors
* At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
* No concurrent steroids
* Recovered from acute toxic effects of all prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation
* No other concurrent anticancer therapy or investigational agents
* No concurrent nonsteroidal anti-inflammatory agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00003528
Study Brief:
Protocol Section:
NCT00003528