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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT01010568
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed CLL or SLL requiring therapy
* Age 18 years of age or older
* ECOG performance status 0, 1, or 2
* Normal organ and bone marrow function
* Resolution of toxic effects from prior therapies
* Ability to adhere to the study schedule and give written informed consent
Exclusion Criteria:
* Any serious medical, psychiatric illness or laboratory abnormality
* Chemotherapy or radiotherapy within 4 weeks of entering the study
* Currently receiving other treatment for CLL/SLL or other malignancies
* Active other malignancies
* History of allergic reactions to bendamustine or ofatumumab
* Ongoing corticosteroid use
* Pregnant or lactating
* HIV positive
* Active hepatitis B
* Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01010568
Study Brief:
Protocol Section:
NCT01010568