Follicular LymphomaPhase 2FLIDVAX2006NCT00530140
Idiotypic Vaccination for Follicular Lymphoma Patients
A Phase 2 study testing Follicular lymphoma, patient-specific, soluble protein idiotype vaccine in people with Follicular Lymphoma and First Relapse/Progression, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Follicular Lymphoma, First Relapse/Progression
- What is being tested?
- Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2007to Sep 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FLIPI score 3 thru 5 at diagnosis and/or at relapse
- First complete response shorter than 3 years, if no maintenance (Interferon, Rituximab, etc) treatment was administered, or than 5 years if maintenance treatment was administered
- No treatment has been able to induce complete response until autologous stem cell transplant
- Poor-prognosis genomic profiling
Who cannot join
- Unavailability of a harvestable lymph node of at least cm 2x2x2
- Life expectancy < 1 year
- Abnormal heart or liver or kidney function
- ECOG Performance Status > 2
- Failure to sign informed consent before enrollment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Navarra Hospital
Pamplona, Navarre, 31008
MAURIZIO BENDANDI, MD, PhD
About this study
Official title: Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following standard first-line treatment) complete response through autologous stem cell transplant prior to vaccination start. The ultimate goal is a cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at least twice as long as each patient's first complete response.
Read the detailed description
Idiotypic vaccination has already proved capable (in responding patients) of: biological efficacy, that is the capacity of inducing an idiotype- and tumor-specific immune response (Kwak LW et al. NEJM 1992); clinical efficacy, that is the capacity of inducing specific immune responses able to kill in vivo follicular lymphoma cells that had survived pre-vaccine chemotherapy (Bendandi M et al. Nature Med 1999): clinical benefit, that is the capacity of prolonging survival of responding patients (Inoges et al. JNCI 2006). Now, we want to test whether it is also capable of contributing to the ultimate goal of preventing relapse indefinitely in responding patients.
- Conditions
- Follicular Lymphoma, First Relapse/Progression
- Being tested
- Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
- Keywords
- Follicular Lymphoma, Idiotype vaccine
- Medical subject headings
- Lymphoma, Follicular, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicular lymphoma, patient-specific, soluble protein idiotype vaccineBiological
0.5 mg of idiotype conjugated to 0.5 mg of KLH + 125 mcg of GM-CSF 5 monthly vaccinations followed by 3 bi-monthly vaccinations, followed by one boost every three months until either relapse or death from cause unrelated to lymphoma
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All patients will receive the same vaccination schedule/formulation Receives: Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
Measured: 15 years
Secondary outcomes (1)
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2013 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria), Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
- Responsible party
- Sponsor
- Investigators
- MAURIZIO BENDANDI, MD, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530140
- Sponsor's protocol ID
- CUN-90-2006
- Acronym
- FLIDVAX2006
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2007
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Inoges S, Rodriguez-Calvillo M, Zabalegui N, Lopez-Diaz de Cerio A, Villanueva H, Soria E, Suarez L, Rodriguez-Caballero A, Pastor F, Garcia-Munoz R, Panizo C, Perez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Espanol de Linfomas/Trasplante Autologo de Medula Oseo study group; Programa para el Estudio y Tratamiento de Hemopatias Malignas study group. Clinical benefit associated with idiotypic vaccination in patients with follicular lymphoma. J Natl Cancer Inst. 2006 Sep 20;98(18):1292-301. doi: 10.1093/jnci/djj358.
PubMed 16985248
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
- ClinicalTrials.gov ID
- NCT00530140
- Acronym / sponsor ID
- FLIDVAX2006 / CUN-90-2006
- Conditions
- Follicular Lymphoma, First Relapse/Progression
- Keywords
- Follicular Lymphoma, Idiotype vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria), Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
- Study start
- Oct 2007
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Sep 2007 (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.
Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following standard first-line treatment) complete response through autologous stem cell transplant prior to vaccination start. The ultimate goal is a cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at least twice as long as each patient's first complete response.
Detailed description
Idiotypic vaccination has already proved capable (in responding patients) of: biological efficacy, that is the capacity of inducing an idiotype- and tumor-specific immune response (Kwak LW et al. NEJM 1992); clinical efficacy, that is the capacity of inducing specific immune responses able to kill in vivo follicular lymphoma cells that had survived pre-vaccine chemotherapy (Bendandi M et al. Nature Med 1999): clinical benefit, that is the capacity of prolonging survival of responding patients (Inoges et al. JNCI 2006). Now, we want to test whether it is also capable of contributing to the ultimate goal of preventing relapse indefinitely in responding patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccineAll patients will receive the same vaccination schedule/formulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FLIPI score 3 thru 5 at diagnosis and/or at relapse
- First complete response shorter than 3 years, if no maintenance (Interferon, Rituximab, etc) treatment was administered, or than 5 years if maintenance treatment was administered
- No treatment has been able to induce complete response until autologous stem cell transplant
- Poor-prognosis genomic profiling
Key exclusion criteria (5 listed)
- Unavailability of a harvestable lymph node of at least cm 2x2x2
- Life expectancy < 1 year
- Abnormal heart or liver or kidney function
- ECOG Performance Status > 2
- Failure to sign informed consent before enrollment
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 |
|---|---|---|
| Follicular lymphoma, patient-specific, soluble protein idiotype vaccine0.5 mg of idiotype conjugated to 0.5 mg of KLH + 125 mcg of GM-CSF 5 monthly vaccinations followed by 3 bi-monthly vaccinations, followed by one boost every three months until either relapse or death from cause unrelated to lymphoma | Biological | A |
Primary outcome
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
Time frame: 15 years
1 secondary outcome
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
Time frame: 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Background: PubMed 16985248Inoges S, Rodriguez-Calvillo M, Zabalegui N, Lopez-Diaz de Cerio A, Villanueva H, Soria E, Suarez L, Rodriguez-Caballero A, Pastor F, Garcia-Munoz R, Panizo C, Perez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Espanol de Linfomas/Trasplante Autologo de Medula Oseo study group; Programa para el Estudio y Tratamiento de Hemopatias Malignas study group. Clinical benefit associated with idiotypic vaccination in patients with follicular lymphoma. J Natl Cancer Inst. 2006 Sep 20;98(18):1292-301. doi: 10.1093/jnci/djj358.
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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.
MAURIZIO BENDANDI, MD, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Follicular lymphoma, patient-specific, soluble protein idiotype vaccine in people with Follicular Lymphoma and First Relapse/Progression, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 4 inclusion and 5 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Contact MAURIZIO BENDANDI, MD, PhD (+34606002087, mbendandi@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured) (time frame: 15 years). 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 NCT00530140, which also lists 1 linked publication.
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 6 Oct 2011.