Completed
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
What is being tested
rituximab
Drug
Who is being recruted
Hemic and Lymphatic Diseases+6
+ Immune System Diseases
+ Immunoproliferative Disorders
Over 40 Years
+29 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: October 2003
Summary
Principal SponsorBiogen
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
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.
Official TitleA Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens
Principal SponsorBiogen
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
168 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
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
Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type
Criteria
10 inclusion criteria required to participate
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.
Show More Criteria
19 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalRituximab
Study 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 45 locations
Suspended
Suspended
USC KECK School of Medicine
Los Angeles, United StatesSuspended
Radiant Research
Honolulu, United StatesSuspended
Carle Clinic Association
Urbana, United StatesCompleted45 Study Centers