Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma
NCT ID: NCT00090038
Last Updated: 2009-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
168 participants
INTERVENTIONAL
2003-10-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Rituximab
rituximab
Dose, schedule,and duration specified in protocol
2
No drug
No interventions assigned to this group
Interventions
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rituximab
Dose, schedule,and duration specified in protocol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Locations
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USC KECK School of Medicine
Los Angeles, California, United States
Radiant Research
Honolulu, Hawaii, United States
Carle Clinic Association
Urbana, Illinois, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Our Lady of Mercy Medical Center
The Bronx, New York, United States
University of Pittsburth Cancer Centers
Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Research Site
Graz, , Austria
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Dijon, , France
Research Site
Lyon, , France
Research Site
Paris, , France
Research Site
Strasbourg, , France
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Frankfurt, , Germany
Research Site
Giessen, , Germany
Research Site
Hamburg, , Germany
Research Site
Koblenz, , Germany
Research Site
Mainz, , Germany
Research Site
Mutlangen, , Germany
Research Site
Tübingen, , Germany
Research Site
Kaunas, , Lithuania
Research Site
Klaipėda, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Brasov, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Craiova, , Romania
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Obninsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Stockholm, , Sweden
Research Site
Gaziantep, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Leeds, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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102-12
Identifier Type: -
Identifier Source: org_study_id
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