Idiotypic Vaccination for Follicular Lymphoma Patients

Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00530140

Acronym

FLIDVAX2006

Enrollment

100

Registered

2007-09-17

Start date

2007-10-31

Completion date

2022-09-30

Last updated

2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Relapse/Progression, Follicular Lymphoma

Keywords

Follicular Lymphoma, Idiotype vaccine

Brief 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 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.

Interventions

BIOLOGICALFollicular lymphoma, patient-specific, soluble protein idiotype vaccine

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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

at least one of the following: * 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

Exclusion criteria

any of the following: * 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

Design outcomes

Primary

Measure	Time frame
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)	15 years

Secondary

Measure	Time frame
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame	15 years

Countries

Spain

Contacts

Primary ContactMAURIZIO BENDANDI, MD, PhD

mbendandi@unav.es+34606002087

Backup ContactSUSANA INOGES, MD, PhD

sinoges@unav.es+34685972257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026