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
rituximab
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.168 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 46 locations
Radiant Research
Honolulu, United StatesCarle Clinic Association
Urbana, United StatesTufts - New England Medical Center
Boston, United States