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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT00525603
Eligibility Criteria:
Inclusion Criteria:
* All patients must have a diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow and be previously untreated.
* All patients must be younger than 70 years and have a serum beta-2 microglobulin of \>/= 4.0mg/L.
* All patients with Rai stage III-IV are eligible for treatment on this protocol. - OR - All patients with Rai stage 0-II who meet one or more indication for treatment as defined by the NCI-sponsored Working Group are eligible for treatment on this protocol.
* All patients must have a Zubrod performance status of 0-3.
* All patients must have adequate renal and hepatic function (serum creatinine \</= 2mg/dL; total bilirubin \</= 2.5mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the Principle Investigator and appropriate dose adjustment considered.
* Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), etc.
* Patients must not have untreated or uncontrolled life-threatening infection.
* Patients must sign informed consent.
Exclusion Criteria:
Patients older than 70 years.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
69 Years
Study:
NCT00525603
Study Brief:
Protocol Section:
NCT00525603