Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma
This study has been completed.
Information provided by:
First received: August 23, 2004
Last updated: October 16, 2009
Last verified: October 2009
The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients [ Time Frame: 8.5 months after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab [ Time Frame: 8.5 months after treatment ] [ Designated as safety issue: No ]
- To determine whether NHL subjects treated with rituximab experience clinically significant changes in antibody titers to a panel of specific antigens [ Time Frame: 8.5 months after treatment ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2007 (Final data collection date for primary outcome measure)
Dose, schedule,and duration specified in protocol
No Intervention: 2
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed IRB-approved informed consent.
- Age >/=40 years.
- Men and women of reproductive potential who are following accepted birth control methods.
- Histologic confirmation of low-grade or follicular, B-cell NHL prior to study entry.
- Relapsed (maximum of 5 relapses) or refractory, low-grade or follicular, CD20+,B-cell NHL.
- WHO performance status </= 2.
- Expected survival >/= 1 year.
- Acceptable hematologic status, liver function, renal function, and pulmonary function.
- Patients must be recovered from all nonhematological toxicities associated with prior surgery, radiation treatments, chemotherapy, biological therapy, bone marrow transplant, investigational drugs, or immunotherapy.
- Known history of tetanus toxoid immunization or positive tetanus titer at the screening visit.
- Active autoimmune disease.
- Exposure to rituximab within 12 months prior to Day 1.
- Chemotherapy within 3 months prior to Day 1.
- Previous immunization with tetanus toxoid within 2 years prior to Day 1.
- Previous exposure to KLH.
- Receipt of intravenous or intramuscular immunoglobulin (IVIG or IMIG) within 30 days of Day 1.
- Known history of hepatitis or other hepatic disease, HIV infection, or AIDS.
- Current use (including "recreational use") of any illicit drugs or history of drug or alcohol abuse within the 5 years prior to Day 1.
- Prior diagnosis of aggressive NHL or mantle-cell lymphoma.
- Chronic lymphocytic leukemia (CLL).
- Small lymphocytic lymphoma (IWF A) with peripheral blood lymphocyte count > 5,000 cells/mm3.
- 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.
- 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.
- Known allergies or contraindications to tetanus toxoid or KLH.
- Known allergy to shellfish.
- Presence of protein-losing enteropathy.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
- Participation in another clinical study 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.
- Pregnant or lactating female subjects
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090038
No publications provided
||Biogen Idec MD, Biogen Idec
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 23, 2004
||October 16, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs