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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00292760
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old
* Written informed consent
* Confirmed diagnosis of CLL or SLL (small mature lymphocytes n blood, bone marrow or lymph nose expressing CD19, CD5, CD23, weakk CD79b, and weak clonally restricted immunoglobin light chain)
* p53 deletion by FISH in at least 20% of leukamia cells
* Treatment is indicated (Binet stage B or C, or stage A with a lyphocyte doubling time of less than 6 months, or disease-related symptoms or complications irrespective of clinical stage)
* WHO performance status 0, 1 or 2
* Both untreated and previously treated patients are eligible for study
Exclusion Criteria:
\- Patients must have none of the following: Active infection Known HIV infection Past history of anaphylaxis following exposure to rat or mouse CDR-grafted humanised monoclonal antibodies Less than 3 weeks since prior chemotherapy Use of prior investigational agents within 6 weeks Pregnancy or lactation Uncontrolled diabetes mellitus Uncontrolled hypertension Active peptic ulcer disease Other severe concurrent diseases or mental disorders Serum urea or creatinine more than twice the upper limit of normal (unless due to uretic obstruction or renal infiltration by CLL/SLL) Serum bilirubin more than twice the upper limit of normal (unless due to haemlysis or liver infiltration with CLL/SLL) Persisting severe cytopenias due to previous therapy rather than disease (neutrophils \<0.5 x 109/l or platelets \<50 x 10/l)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00292760
Study Brief:
Protocol Section:
NCT00292760