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:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00285103
Eligibility Criteria:
Inclusion Criteria:
* patients with relapsed or refractory Chronic Lymphocytic Leukaemia requiring therapy
* screening blood sample must show circulating lymphocyte count of more then 5 x 109/L and circulating lymphocytes expressing the phenotype CD5+CD20+CD23+.
* The PCR Bcl-2 m-RNA level must be positive
* the patients must be 18 years or older and have given informed consent.
Exclusion Criteria:
* previous treatment with rituximab, alemtuzumab or autologous stem cell transplantation within 6 months prior to Visit 1 or allogeneic stem cell transplantation at any time
* patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4 weeks prior to Visit 1 and patients with known or suspected transformation of CLL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00285103
Study Brief:
Protocol Section:
NCT00285103