Clinical trial NCT00090038: Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2004-08-24
Enrollment: 168
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients
timeFrame: 8.5 months after treatment
Secondary outcomes:
measure: To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
timeFrame: 8.5 months after treatment
measure: To determine whether NHL subjects treated with rituximab experience clinically significant changes in antibody titers to a panel of specific antigens
timeFrame: 8.5 months after treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC KECK School of Medicine
state: California
city: Honolulu
country: United States
facility: Radiant Research
state: Hawaii
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburth Cancer Centers
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Graz
country: Austria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Giessen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mutlangen
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
References: