Non-Hodgkins LymphomaPhase 3BiovaxIDNCT00091676
Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
A Phase 3 study testing FNHLId1 and KLH + GM-CSF in people with Non-Hodgkins Lymphoma, run by Biovest International.
Trial summary
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkins Lymphoma
- What is being tested?
- FNHLId1 and KLH + GM-CSF
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2012
- Phase
- Phase 3
- 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
- Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
- Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm
- No prior chemotherapy other than local radiation (not greater than 2 sites)
- ECOG < 2
- Survival > 1 yr
- Serum creatinine < 1.5 mg/dl
Show all 12Show fewer
- Bilirubin <1.5 mg/dl
- SGOT/SGPT < 3.5 ULN
- No HIV antibodies or HBV antigen
- Negative pregnancy screen (females)
- No unrelated neoplasm in the previous 10 years
- No evidence of primary or secondary CNS lymphoma
Who cannot join
None listed.
About this study
Official title: Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.
Read the detailed description
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
- Conditions
- Non-Hodgkins Lymphoma
- Being tested
- FNHLId1, KLH + GM-CSF
- Keywords
- follicular, lymphoma, Non-Hodgkins, idiotype, vaccine, indolent follicular Non-Hodgkins Lymphoma, tumor-derived, B-cell, cancer
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNHLId1Biological
5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
KLH + GM-CSFBiological
5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
| Study group | Role | What they receive |
|---|---|---|
| ID-KLH + GM-CSF | Experimental | Not described Receives: Biological: FNHLId1 |
| KLH + GM-CSF | Active comparator | Not described Receives: Biological: KLH + GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
Measured: until date of relapse
Secondary outcomes (5)
To determine the ability of the idiotype vaccine to produce a molecular complete remission
Measured: once subject achieves molecular CR
To determine the impact of molecular disease free survival
Measured: until relapse
To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor
Measured: varies
To compare the overall survival of subjects randomized to receive either treatment
Measured: minimum 5 years from last subject randomized
To confirm the safety of 5 monthly injections of the vaccine with GM-CSF
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2004 (estimated)
- Study startJan 2000
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkins 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 629 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biovest International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos F Santos, PhD, Study director, Biovest InternationalStephen J Schuster, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091676
- Sponsor's protocol ID
- BV 301
- Acronym
- BiovaxID
- Status last verified
- Feb 2012
- First submitted
- 15 Sep 2004
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu FJ, Caspar CB, Czerwinski D, Kwak LW, Liles TM, Syrengelas A, Taidi-Laskowski B, Levy R. Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma--long-term results of a clinical trial. Blood. 1997 May 1;89(9):3129-35.
PubMed 9129015Bendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, Watson TM, Reynolds CW, Gause BL, Duffey PL, Jaffe ES, Creekmore SP, Longo DL, Kwak LW. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat Med. 1999 Oct;5(10):1171-7. doi: 10.1038/13928.
PubMed 10502821Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15. doi: 10.1056/NEJM199210223271705.
PubMed 1406793Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. doi: 10.1007/s11912-003-0022-x.
PubMed 12895388Schuster SJ, Neelapu SS, Gause BL, Janik JE, Muggia FM, Gockerman JP, Winter JN, Flowers CR, Nikcevich DA, Sotomayor EM, McGaughey DS, Jaffe ES, Chong EA, Reynolds CW, Berry DA, Santos CF, Popa MA, McCord AM, Kwak LW. Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. J Clin Oncol. 2011 Jul 10;29(20):2787-94. doi: 10.1200/JCO.2010.33.3005. Epub 2011 May 31.
PubMed 21632504
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
- ClinicalTrials.gov ID
- NCT00091676
- Acronym / sponsor ID
- BiovaxID / BV 301
- Conditions
- Non-Hodgkins Lymphoma
- Keywords
- follicular, lymphoma, Non-Hodgkins, idiotype, vaccine, indolent follicular Non-Hodgkins Lymphoma, tumor-derived, B-cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 629 participants (estimated)
- Lead sponsor
- Biovest InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Sep 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 primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.
Detailed description
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ID-KLH + GM-CSF | Experimental | Biological: FNHLId1 |
| KLH + GM-CSF | Active comparator | Biological: KLH + GM-CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
- Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm
- No prior chemotherapy other than local radiation (not greater than 2 sites)
- ECOG < 2
- Survival > 1 yr
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FNHLId15 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4 | Biological | ID-KLH + GM-CSF |
| KLH + GM-CSF5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4 | Biological | KLH + GM-CSF |
Primary outcome
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
Time frame: until date of relapse
5 secondary outcomes
To determine the ability of the idiotype vaccine to produce a molecular complete remission
Time frame: once subject achieves molecular CR
To determine the impact of molecular disease free survival
Time frame: until relapse
To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor
Time frame: varies
To compare the overall survival of subjects randomized to receive either treatment
Time frame: minimum 5 years from last subject randomized
To confirm the safety of 5 monthly injections of the vaccine with GM-CSF
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Background: PubMed 9129015Hsu FJ, Caspar CB, Czerwinski D, Kwak LW, Liles TM, Syrengelas A, Taidi-Laskowski B, Levy R. Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma--long-term results of a clinical trial. Blood. 1997 May 1;89(9):3129-35.
- Background: PubMed 10502821Bendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, Watson TM, Reynolds CW, Gause BL, Duffey PL, Jaffe ES, Creekmore SP, Longo DL, Kwak LW. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat Med. 1999 Oct;5(10):1171-7. doi: 10.1038/13928.
- Background: PubMed 1406793Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15. doi: 10.1056/NEJM199210223271705.
- Background: PubMed 12895388Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. doi: 10.1007/s11912-003-0022-x.
- Results publication: PubMed 21632504Schuster SJ, Neelapu SS, Gause BL, Janik JE, Muggia FM, Gockerman JP, Winter JN, Flowers CR, Nikcevich DA, Sotomayor EM, McGaughey DS, Jaffe ES, Chong EA, Reynolds CW, Berry DA, Santos CF, Popa MA, McCord AM, Kwak LW. Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. J Clin Oncol. 2011 Jul 10;29(20):2787-94. doi: 10.1200/JCO.2010.33.3005. Epub 2011 May 31.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Carlos F Santos, PhD study director
Biovest International
Stephen J Schuster, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FNHLId1 and KLH + GM-CSF in people with Non-Hodgkins Lymphoma, run by Biovest International.
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 12 inclusion and 0 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 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients (time frame: until date of relapse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091676, which also lists 5 linked publications.
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 3 Feb 2012.