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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090038
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : October 20, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: rituximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 1
Drug: rituximab
Dose, schedule,and duration specified in protocol

No Intervention: 2
No drug

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab [ Time Frame: 8.5 months after treatment ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090038

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Sponsors and Collaborators
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Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00090038    
Other Study ID Numbers: 102-12
First Posted: August 24, 2004    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents