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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT00575068
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy
* Progressive disease requiring further treatment
* Bidimensionally measurable disease
* Acceptable hematologic status
* Prestudy WHO performance status of 0, 1, or 2
* Expected survival of \>/= 3 months
* Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment
* Female patients must not be pregnant or lactating
* Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs
Exclusion Criteria:
* Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)
* Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment
* Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment
* Previous exposure to IDEC-114 or any anti-CD80 antibody
* ABMT within 6 months prior to first scheduled treatment
* Abnormal liver function
* Abnormal renal function
* Presence of chronic lymphocytic leukemia (CLL)
* Presence of CNS lymphoma
* Presence of HIV infection or AIDS
* Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma
* Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
* Serious nonmalignant disease which 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 first scheduled treatment
* Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment
* Pleural invasion and/or effusion with positive cytology for lymphoma
* Peritoneal invasion and/or ascites with positive cytology for lymphoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00575068
Study Brief:
Protocol Section:
NCT00575068