Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090038
• Other study ID #: 102-12
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2004
• Last updated: October 16, 2009
• Start date: October 2003
• Est. completion date: November 2007

Study information

• Verified date: October 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: November 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• rituximab
Dose, schedule,and duration specified in protocol

Locations

Country	Name	City	State
Austria	Research Site	Graz
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 2
France	Research Site	Dijon
France	Research Site	Lyon
France	Research Site	Paris
France	Research Site	Strasbourg
Germany	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	Tubingen
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Vilnius
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Craiova
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Saint Petersburg
Sweden	Research Site	Stockholm
Turkey	Research Site	Gaziantep
Turkey	Research Site	Izmir
Turkey	Research Site	Kayseri
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Sheffield
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Our Lady of Mercy Medical Center	Bronx	New York
United States	Radiant Research	Honolulu	Hawaii
United States	USC KECK School of Medicine	Los Angeles	California
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	Carle Clinic Association	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Austria,  Czech Republic,  France,  Germany,  Lithuania,  Romania,  Russian Federation,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab		8.5 months after treatment	No
Secondary	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	No