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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00090038
First received: August 23, 2004
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab [ Time Frame: 8.5 months after treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: October 2003
Study Completion Date: November 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rituximab
Drug: rituximab
Dose, schedule,and duration specified in protocol
No Intervention: 2
No drug

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090038

  Show 46 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00090038     History of Changes
Other Study ID Numbers: 102-12
Study First Received: August 23, 2004
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014