A Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens - 102-12

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. A signed, written informed consent form that has been approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
2. Age equal to or greater than 40 years.
3. Subjects of reproductive potential must agree to follow accepted birth control methods for the duration of the study.
4. Relapsed (maximum of 5 relapses) or refractory, low-grade or follicular, CD20+, B-cell NHL.
5. Histological confirmation of low-grade or follicular, B-cell NHL prior to study entry.
6. Prestudy WHO performance status of 0, 1, or 2.
7. Expected survival equal to or greater than 1 year.
8. Acceptable hematologic status:
- Platelet count equal to or greater than 75,000 plts/mm3.
- Total White Blood Cell (WBC) count equal to or greater than 3000 cells/mm3.
- Hemoglobin equal to or greater than 8.0 g/dL.
9. Acceptable liver function:
- Bilirubin equal to or less than 2.0 mg/dL (26 micromol/L).
- Alkaline phosphatase, ALT (SGPT) and AST (SGOT) equal to or less than 2 times upper limit of normal (ULN).
10. Acceptable renal function: Serum creatinine equal to or less than 2.0 mg/dL (177 micromol/L).
11. Fully recovered from all nonhematological toxicities associated with prior surgery, radiation treatments, chemotherapy, biological therapy, bone marrow transplant, investigational drugs, or immunotherapy.
12. Known history of tetanus toxoid immunization or positive tetanus titer at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Active autoimmune disease.
2. Exposure to rituximab within 12 months prior to Day 1.
3. Chemotherapy within 3 months prior to Day 1.
4. Previous immunization with tetanus toxoid within 2 years prior to Day 1.
5. Previous exposure to Keyhole Limpet Hemocyanin (KLH).
6. Receipt of intravenous or intramuscular immunoglobulin (IVIG or IMIG) within 30 days of Day 1.
7. Known history of hepatitis or other hepatic disease HIV infection or AIDS.
8. Current use (including recreational use) of any illicit drugs or history of drug or alcohol abuse within the 5 years prior to Day 1.
9. Prior diagnosis of aggresive NHL or mantle-cell lymphoma.
10. Chronic lymphocytic leukemia (CLL).
11. Small lymphocytic lymphoma (IWF A) with peripheral blood lymphocyte count greater than 5,000 cells/mm3.
12. History of other primary malignancy, with the exception of squamous cell carcinoma or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer for which the subject has not been disease-free for at least 3 years.
13. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active, uncontrolled bacterial, viral or fungal infection or any other condition that would compromise protocol objectives in the opinion of the investigator and/or sponsor.
14. Known allergies or contraindications to tetanus toxoid or KLH.
15. Known allergy to shellfish.
16. Presence of protein-losing enteropathy.
17. Major surgery other that diagnostic surgery, within 4 weeks prior to Day1.
18. Participation in another clinical trial with an investigational agent or device within the last year. The subject cannot participate in any other clinical study with an investigational agent or device during the course of this study.
19. Pregnant or lactating female subjects.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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