Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
168
11 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2003
Longer than P75 for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 23, 2004
CompletedFirst Posted
Study publicly available on registry
August 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedOctober 20, 2009
October 1, 2009
3.7 years
August 23, 2004
October 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients
8.5 months after treatment
Secondary Outcomes (2)
To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
8.5 months after treatment
To determine whether NHL subjects treated with rituximab experience clinically significant changes in antibody titers to a panel of specific antigens
8.5 months after treatment
Study Arms (2)
1
EXPERIMENTALRituximab
2
NO INTERVENTIONNo drug
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (45)
USC KECK School of Medicine
Los Angeles, California, 90033, United States
Radiant Research
Honolulu, Hawaii, 96814, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
Our Lady of Mercy Medical Center
The Bronx, New York, 10466, United States
University of Pittsburth Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Research Site
Graz, Austria
Research Site
Brno, Czechia
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Hradec Králové, Czechia
Research Site
Olomouc, Czechia
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Prague, Czechia
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Dijon, France
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Lyon, France
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Paris, France
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Strasbourg, France
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Berlin, Germany
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Bonn, Germany
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Frankfurt, Germany
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Giessen, Germany
Research Site
Hamburg, Germany
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Koblenz, Germany
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Mainz, Germany
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Mutlangen, Germany
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Tübingen, Germany
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Brasov, Romania
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Bucharest, Romania
Research Site
Cluj-Napoca, Romania
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Craiova, Romania
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Moscow, Russia
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Saint Petersburg, Russia
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Yekaterinburg, Russia
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Stockholm, Sweden
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Gaziantep, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Leeds, United Kingdom
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Leicester, United Kingdom
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Manchester, United Kingdom
Research Site
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2004
First Posted
August 24, 2004
Study Start
October 1, 2003
Primary Completion
June 1, 2007
Study Completion
November 1, 2007
Last Updated
October 20, 2009
Record last verified: 2009-10