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 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT00645606
Eligibility Criteria:
Inclusion criteria
* B-CLL
* Matutes score 4 or 5
* Binet stages B or C
* Age \> 65 years old
* No previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy, except glucocorticoids \< 1 month
* Patient's written informed consent
* Life expectancy \> 6 months
Exclusion criteria
* Binet stage A
* ECOG performance status 2 or more
* Presence of a 17p deletion by FISH (\> 10% positive cores)
* Clinically significant auto-immune cytopenia, Coombs-positive hemolytic anemia as judged by the treating physician
* Patients with a history of another malignancy in complete remission less than 5 years, except basal cell skin cancer or tumor treated curatively by surgery
* Concomitant disease requiring prolonged use of corticosteroids (\> 1 month)
* Any severe co-morbidities such as NYHA Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, severe uncontrolled myocardiopathy, uncontrolled hypertension, severe chronic obstructive pulmonary disease with hypoxemia, or uncontrolled diabetes mellitus.
* CIRS (Cumulative Illness rating Scale) \> 6
* Known hypersensitivity to murine proteins or to any of the study drugs or to their components
* Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma) or prolymphocytic leukemia
* Active bacterial, viral or fungal infection
* Seropositivity HIV, hepatitis C or hepatitis B (unless clearly due to vaccination)
* Total bilirubin, alkaline phosphatases and aminotransferases \> 2 x ULN
* Creatinine clearance \< 60 ml/min calculated according to the formula of Cockcroft and Gault
* Any coexisting medical or psychological condition that would preclude participation to the required study procedures
* Patient with mental deficiency preventing proper understanding of the requirements of treatment
Inclusion criteria at randomization
* Patients having received the full induction phase with 4 FC and 6 rituximab courses (with/without dose adjustments as per protocol)
* Complete or partial response according to NCI and iwCLL criteria at the end of induction phase
* Recovery from FCR toxicities
* Patient willingness to continue on protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00645606
Study Brief:
Protocol Section:
NCT00645606