Non-Hodgkin's LymphomaPhase 4NCT00090038
Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma
A Phase 4 study testing rituximab in people with Non-Hodgkin's Lymphoma, run by Biogen at 45 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 45 sitesin 11 countries
- Study dates
- Oct 2003to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
45 sites in 11 countries.
45 sites in 11 countries
Germany9 sites
Research Site
Berlin
Research Site
Bonn
Research Site
Frankfurt
Research Site
Giessen
Research Site
Hamburg
Research Site
Koblenz
Research Site
Mainz
Research Site
Mutlangen
Research Site
Tübingen
United States7 sites
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Radiant Research
Honolulu, Hawaii, 96814
USC KECK School of Medicine
Los Angeles, California, 90033
University of Pittsburth Cancer Centers
Pittsburgh, Pennsylvania, 15232
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Our Lady of Mercy Medical Center
The Bronx, New York, 10466
Carle Clinic Association
Urbana, Illinois, 61801
Russia5 sites
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Obninsk
Research Site
Saint Petersburg
Research Site
Yekaterinburg
Czechia4 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Olomouc
Research Site
Prague
France4 sites
Research Site
Dijon
Research Site
Lyon
Research Site
Paris
Research Site
Strasbourg
Romania4 sites
Research Site
Brasov
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Craiova
United Kingdom4 sites
Research Site
Leeds
Research Site
Leicester
Research Site
Manchester
Research Site
Sheffield
Lithuania3 sites
Research Site
Kaunas
Research Site
Klaipėda
Research Site
Vilnius
Turkey (Türkiye)3 sites
Research Site
Gaziantep
Research Site
Izmir
Research Site
Kayseri
About this study
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
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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Dose, schedule,and duration specified in protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rituximab Receives: Drug: rituximab |
| 2 | No intervention | No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patients
Measured: 8.5 months after treatment
Secondary outcomes (2)
To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
Measured: 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
Measured: 8.5 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2004 (estimated)
- Study startOct 2003
- Primary completionJun 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090038
- Sponsor's protocol ID
- 102-12
- Status last verified
- Oct 2009
- First submitted
- 23 Aug 2004
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00090038
- Acronym / sponsor ID
- 102-12
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rituximabRituximab |
| 2 | No intervention | –No drug |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabDose, schedule,and duration specified in protocol | Drug | 1 |
Primary outcome
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
2 secondary outcomes
To determine whether NHL patients can mount a primary response to KLH after treatment with rituximab
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rituximab in people with Non-Hodgkin's Lymphoma, run by Biogen at 45 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, United States, Russia, Czechia, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.