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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT00558961
Eligibility Criteria:
Inclusion Criteria:
* B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.
* Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
* White blood cell count \> 25 x 10\^9/L
* ECOG 0, 1,or 2.
* Adequate renal and hepatic function
* Platelets \> 75 x 10\^9/L, transfusion independent.
* Neutrophils \> 1.0 x 10\^9/L, transfusion independent
Exclusion Criteria:
* Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)
* Active cardiovascular disease as defined by NYHA class III-IV categorization.
* Intercurrent illness or medical condition precluding safe administration of ribavirin.
* Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
* Known infection with HIV, Hepatitis B or C.
* Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
* Received any previous therapy for CLL within 28 days prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00558961
Study Brief:
Protocol Section:
NCT00558961