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

October 16, 2009 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Praha 10, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
  • France
      • Dijon, France
        • Research Site
      • Lyon, France
        • Research Site
      • Paris, France
        • Research Site
      • Strasbourg, France
        • Research Site
  • Germany
      • 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, Germany
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Klaipeda, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Obninsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
  • Sweden
      • Stockholm, Sweden
        • Research Site
  • Turkey
      • Gaziantep, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Kayseri, Turkey
        • Research Site
  • United Kingdom
      • Leeds, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Radiant Research
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TUFTS - New England Medical Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburth Cancer Centers
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rituximab
Drug: rituximab
Dose, schedule,and duration specified in protocol
No Intervention: 2
No drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients
Time Frame: 8.5 months after treatment
8.5 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
Time Frame: 8.5 months after treatment
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
Time Frame: 8.5 months after treatment
8.5 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 23, 2004

First Submitted That Met QC Criteria

August 23, 2004

First Posted (Estimate)

August 24, 2004

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 16, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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