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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT00466895
Eligibility Criteria:
Inclusion Criteria:
* Blood blast count must be \< 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count \< 40,000/uL
* ECOG(Eastern Cooperative Oncology Group)performance status 0-2.
* Patients with CNS(central nervous system)involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF (cerebrospinal fluid)following intrathecal chemotherapy or radiation.
Exclusion Criteria:
* Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
* Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
* CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
* Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
* Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine \>2.0 mg/dl Total bilirubin \> 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST \> 5 x upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00466895
Study Brief:
Protocol Section:
NCT00466895