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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01118234
Eligibility Criteria:
Inclusion Criteria:
* B-CLL
* Age \>18
* ECOG performance status 0-2
* Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
* Patient must be in complete remission or partial remission after an induction treatment containing rituximab
* ANC (absolute neutrophil count) \> 1,0 x 10e9 /L
* Life expectancy \> 6 months
* Patient´s written informed consent
* Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter
Exclusion Criteria:
* Active uncontrolled bacterial, viral or fungal infection
* Significantly reduced organ functions and bone marrow dysfunction not due to CLL
* creatinine clearance of below 30mL/min
* Patients with a history of other malignancies within 2 years prior to study entry
* Patients with a history of severe cardiac disease
* Other known comorbidity with the potential to dominate survival
* Transformation to aggressive B-cell malignancy
* Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
* Medical condition requiring prolonged (\> 1 month) use of oral corticosteroids
* Pregnant or breast feeding women
* Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01118234
Study Brief:
Protocol Section:
NCT01118234