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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT00880867
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be at least 18 years of age.
2. Patients must have biopsy confirmed low-grade B-cell lymphoma (follicular, marginal zone, or small cell/chronic lymphocytic leukemia) or mycosis fungoides. B-cell lymphoma patients must have failed at least one prior therapy (chemotherapy or immunotherapy) or mycosis fungoides patients failed at least 1 topical or systemic treatment.
3. Patients must have at least one accessible tumor site that can be injected with poly-ICLC.
4. Patients must have measurable disease other than the injection site.
5. Patients must have a Karnofsky performance status of at least 70%.
6. Patients must have adequate hematologic, renal and liver function (i.e., absolute neutrophil count at least 1500/mm3, Platelets at least 100,000/mm3, creatinine no more than 1.7 mg/dl, total bilirubin no more than 1.5 mg/dl, transaminases no more than 4 times above the upper limits of the institutional normal).
7. Patients must be able to provide written informed consent.
8. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. While animal testing has been negative, the anti-proliferative activity of this experimental drug may theoretically be harmful to the developing fetus or nursing infant.
9. Required washout period for prior therapy:
* Topical therapy: 2 weeks.
* Chemotherapy: 4 weeks
* Radiotherapy: (including phototherapy): 4 weeks 13 of 26
* Biological therapies: 4 weeks
* Other investigational therapy: 4 weeks
* Rituximab: 12 weeks
Exclusion Criteria:
1. Any history of autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, autoimmune hemolytic anemia, pure red cell aplasia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
2. Off nucleoside or bendustine therapy for a minimum of 6 months
3. Prior treatment with Campath
4. Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both).
5. Patients with active infection or with a fever \> 38.5°C within three days prior to the first scheduled treatment.
6. CNS metastases.
7. Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.
8. Current anticoagulant therapy (ASA no more than 325 mg/day allowed).
9. Significant cardiovascular disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
10. Pregnant or lactating.
11. Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00880867
Study Brief:
Protocol Section:
NCT00880867