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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00892827
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis: advanced (Rai stage ≥2 or symptomatic stage 1) CLL Resistant to or relapsing after treatment with Fludarabine and/or Rituximab
* Lymphocyte count of 100,000 cells/mcl or higher.
* Time from last anti-leukemia treatment: 1 month or more
* Age: male or female over 18 years of age.
* Informed consent - obtained
Exclusion Criteria:
* Lack of one or more of the inclusion criteria
* Known sensitivity to human plasma
* Known sensitivity to Rituximab (Mabthera)
* Active second malignant disease (other than non-melanoma skin cancer) \< 2 years prior to the study
* Active infectious disease \< 1 month prior to the study
* Hepatitis B serology: Hepatitis B surface antigen - positive
* Renal function: Creatinin \> 3 mg/dL
* Liver function: Liver enzymes less than x2 of the normal values
* Performance status: ECOG performance status 4
* Use of other investigational agent \< 30 days ago
* Known poor adherence to treatment plan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00892827
Study Brief:
Protocol Section:
NCT00892827