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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00564512
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion
Diagnosis of B-cell chronic lymphocytic leukemia (CLL), meeting the following criteria:
* Binet classification stages B or C
* Del 17 p (FISH) negative (\< 10 % positives cores)
* Matutes score 4 or 5
Exclusion Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukemia)
PATIENT CHARACTERISTICS:
Exclusion ECOG performance status ≥ 2
* Life expectancy \< 6 months
* Creatinine clearance \< 60 mL/min
* Total bilirubin \> 2 x upper limit of normal (ULN)
* Gamma glutamyltransferase or transaminase levels \> 2 x ULN
* Cumulative illness rating scale \> 6
* HIV seropositivity
* Hepatitis B or C seropositivity (unless clearly due to vaccination)
* Clinically significant autoimmune anemia
* Active bacterial, viral, or fungal infection
* Active second malignancy currently requiring treatment (except basal cell carcinoma or in situ endometrial carcinoma) and/or less than 5 years complete remission after breast cancer
* Any severe comorbid conditions including, but not limited to, any of the following:
* Class III or IV heart failure
* Recent myocardial infarction
* Unstable angina
* Ventricular tachyarrhythmias requiring ongoing treatment
* Severe chronic obstructive pulmonary disease with hypoxemia
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Concomitant disease requiring prolonged use of corticosteroids (\> 1 month)
* Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
* Contraindication to the use of rituximab or alemtuzumab according to Summary of Product Characteristics
* Any coexisting medical or psychological condition that would preclude participation in the required study procedures
* Any mental deficiency preventing proper understanding of the requirements of treatment
* Person under law control
* Pregnant or breastfeeding women
* Fertile patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
PRIOR CONCURRENT THERAPY:
Inclusion
* No prior chemotherapy, radiotherapy, or immunotherapy for CLL
* Corticosteroids within the past month allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00564512
Study Brief:
Protocol Section:
NCT00564512