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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
rituximab
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC KECK School of Medicine
  • Radiant Research
  • Carle Clinic Association
  • Tufts - New England Medical Center
  • Our Lady of Mercy Medical Center
  • University of Pittsburth Cancer Centers
  • University of Texas Health Science Center at San Antonio
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Rituximab

No drug

Outcomes

Primary Outcome Measures

To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients

Secondary Outcome Measures

To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
To determine whether NHL subjects treated with rituximab experience clinically significant changes in antibody titers to a panel of specific antigens

Full Information

First Posted
August 23, 2004
Last Updated
October 16, 2009
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00090038
Brief Title
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

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Rituximab
Arm Title
2
Arm Type
No Intervention
Arm Description
No drug
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
Dose, schedule,and duration specified in protocol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
Time Frame
8.5 months after treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
USC KECK School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Radiant Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Our Lady of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
University of Pittsburth Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Research Site
City
Graz
Country
Austria
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Dijon
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bonn
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Giessen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Koblenz
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Mutlangen
Country
Germany
Facility Name
Research Site
City
Tubingen
Country
Germany
Facility Name
Research Site
City
Kaunas
Country
Lithuania
Facility Name
Research Site
City
Klaipeda
Country
Lithuania
Facility Name
Research Site
City
Vilnius
Country
Lithuania
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
Country
Romania
Facility Name
Research Site
City
Craiova
Country
Romania
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Gaziantep
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Kayseri
Country
Turkey
Facility Name
Research Site
City
Leeds
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

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

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