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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00090038

Collaborator

(none)

168

Enrollment

Locations

Arms

Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab	Phase 4

Study Design

Study Type:

Interventional

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 :

Oct 1, 2003

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Rituximab

Drug: rituximab

Dose, schedule,and duration specified in protocol

No Intervention: 2

No drug

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab [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 [8.5 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC KECK School of Medicine	Los Angeles	California	United States	90033
2	Radiant Research	Honolulu	Hawaii	United States	96814
3	Carle Clinic Association	Urbana	Illinois	United States	61801
4	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
5	Our Lady of Mercy Medical Center	Bronx	New York	United States	10466
6	University of Pittsburth Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
7	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
8	Research Site	Graz		Austria
9	Research Site	Brno		Czech Republic
10	Research Site	Hradec Kralove		Czech Republic
11	Research Site	Olomouc		Czech Republic
12	Research Site	Praha 10		Czech Republic
13	Research Site	Praha 2		Czech Republic
14	Research Site	Dijon		France
15	Research Site	Lyon		France
16	Research Site	Paris		France
17	Research Site	Strasbourg		France
18	Research Site	Berlin		Germany
19	Research Site	Bonn		Germany
20	Research Site	Frankfurt		Germany
21	Research Site	Giessen		Germany
22	Research Site	Hamburg		Germany
23	Research Site	Koblenz		Germany
24	Research Site	Mainz		Germany
25	Research Site	Mutlangen		Germany
26	Research Site	Tubingen		Germany
27	Research Site	Kaunas		Lithuania
28	Research Site	Klaipeda		Lithuania
29	Research Site	Vilnius		Lithuania
30	Research Site	Brasov		Romania
31	Research Site	Bucharest		Romania
32	Research Site	Cluj-Napoca		Romania
33	Research Site	Craiova		Romania
34	Research Site	Ekaterinburg		Russian Federation
35	Research Site	Moscow		Russian Federation
36	Research Site	Nizhniy Novgorod		Russian Federation
37	Research Site	Obninsk		Russian Federation
38	Research Site	Saint Petersburg		Russian Federation
39	Research Site	Stockholm		Sweden
40	Research Site	Gaziantep		Turkey
41	Research Site	Izmir		Turkey
42	Research Site	Kayseri		Turkey
43	Research Site	Leeds		United Kingdom
44	Research Site	Leicester		United Kingdom
45	Research Site	Manchester		United Kingdom
46	Research Site	Sheffield		United Kingdom

Sponsors and Collaborators

Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00090038

Other Study ID Numbers:

102-12

First Posted:

Aug 24, 2004

Last Update Posted:

Oct 20, 2009

Last Verified:

Oct 1, 2009

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Rituximab

Study Results

No Results Posted as of Oct 20, 2009