Non-Hodgkin's LymphomaPhase 2NCT00041730
Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma
A Phase 2 study testing Id-KLH in people with Non-Hodgkin's Lymphoma, run by Favrille at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Id-KLH
- How many people
- 90 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2002to not given
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients that are treatment naive OR
- Relapsed or refractory following chemotherapy OR
- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease.
- Tumor accessible for biopsy or previously existing recent biopsy material
- Measurable disease after node biopsy
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- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
- Performance status (ECOG) of 0, 1 or 2
- Absolute Granulocyte count > 1,000/mm3
- Platelets > 100,000/mm3
- Total Bilirubin <2 mg/dL
- AST and ALT <2x Upper Limit of Normal
- Creatinine < 1.5 mg/dL
Who cannot join
- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory
- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens)
- Treatment w/Fludarabine within 9 months of study entry
- Patients with > 5,000 lymphocytes
- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype)
- Concurrent immunosuppressive therapy (high-dose steroids; ect.)
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- Known history of CNS lymphoma or meningeal lymphomatosis
- HIV positive
- Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), congestive heart failure, or active uncontrolled bacterial, viral or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
- Prior malignancy (excluding non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for >2 years
- Treatment with an investigational drug within 8 weeks prior to study entry
- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Virginia
Charlottesville, Virginia, 22902
Northwestern University
Chicago, Illinois, 60611
Oncology/Hematology Care Clinical Cancer Institute
Cincinnati, Ohio, 45219
University Hospitals of Cleveland Case Western, Ireland Cancer Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida, Jacksonville
Jacksonville, Florida, 32209
University of California, San Diego
La Jolla, California, 92093
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Ochsner Clinical Foundation
New Orleans, Louisiana, 70121
Oncology Associates of San Diego
San Diego, California, 92123
University California, San Francisco
San Francisco, California, 94143
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466
About this study
Official title: Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Read the detailed description
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype. Secondary objectives are the determination of overall objective response rate, duration of response and time to progression. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in production of unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. For vaccines which produce primarily an antibody response, there is a concern that combining immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH will be measured during this trial.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Id-KLH
- Keywords
- lymphoma, vaccine, idiotype, KLH, GM-CSF, FavId
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Id-KLHBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2002 (estimated)
- Study startJul 2002
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Favrille
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041730
- Sponsor's protocol ID
- FavId-04
- Status last verified
- Oct 2004
- First submitted
- 15 Jul 2002
- Last updated
- 30 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00041730
- Acronym / sponsor ID
- FavId-04
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- lymphoma, vaccine, idiotype, KLH, GM-CSF, FavId
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- FavrilleIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- First posted
- 17 Jul 2002 (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 evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Detailed description
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype. Secondary objectives are the determination of overall objective response rate, duration of response and time to progression. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in production of unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. For vaccines which produce primarily an antibody response, there is a concern that combining immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH will be measured during this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age or older
- Patients that are treatment naive OR
- Relapsed or refractory following chemotherapy OR
- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease.
- Tumor accessible for biopsy or previously existing recent biopsy material
Key exclusion criteria (12 listed)
- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory
- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens)
- Treatment w/Fludarabine within 9 months of study entry
- Patients with > 5,000 lymphocytes
- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype)
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 |
|---|---|---|
| Id-KLH | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Id-KLH in people with Non-Hodgkin's Lymphoma, run by Favrille at 15 sites in United States.
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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 30 Sep 2009.