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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00384150
Eligibility Criteria:
Key Inclusion Criteria:
* Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP \>=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).
* Bidimensionally measurable disease with at least 1 lesion \>=2.0 cm in a single dimension.
* Acceptable hematologic, hepatic, and renal function.
Key Exclusion Criteria:
* Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.
* Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.
* Transfusion-dependent subjects.
* Presence of central nervous system (CNS) lymphoma.
* Histologic transformation.
* Presence of pleural or peritoneal effusion with positive cytology for lymphoma.
* Another primary malignancy requiring active treatment.
* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00384150
Study Brief:
Protocol Section:
NCT00384150