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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00800566
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB \[French-American-British Classification\]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
* Absolute neutrophil count (ANC) \>= 1 x 109/L and platelet count \>= 50 x 109/L.
* Adequate organ function as indicated by the following laboratory values: serum creatinine \</= 1 mg/dL; if serum creatinine \> 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin \</= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) \</= 2.5 x ULN; alkaline phosphatase \</= 2.5 x ULN.
* ECOG performance status \<= 2.
* Age \>/= 18 years.
Exclusion Criteria:
* Patients with NYHA \>/= grade 3 heart disease as assessed by history and/or physical examination.
* Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
* Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).
* Other malignancy within 3 years except in situ carcinoma.
* Unwilling or unable to provide informed consent.
* Known hypersensitivity to nucleoside analogues.
* Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00800566
Study Brief:
Protocol Section:
NCT00800566