Idiotypic Vaccination for Follicular Lymphoma Patients

Trial Title: Idiotypic Vaccination for Follicular Lymphoma Patients

NCT ID: NCT00530140

Condition: Follicular Lymphoma
First Relapse/Progression

Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Recurrence
Immunoglobulin Idiotypes

Conditions: Keywords:
Follicular Lymphoma
Idiotype vaccine

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
Description: 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
Arm group label: A

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Navarra Hospital

Address:
City: Pamplona
Zip: 31008
Country: Spain

Status: Recruiting

Investigator:
Last name: MAURIZIO BENDANDI, MD, PhD
Email: Principal Investigator

Start date: October 2007

Completion date: September 2022

Lead sponsor:
Agency: Clinica Universidad de Navarra, Universidad de Navarra
Agency class: Other

Collaborator:
Agency: University of Navarrra Hospital (Clinica Universitaria)
Agency class: Other

Collaborator:
Agency: Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
Agency class: Other

Source: Clinica Universidad de Navarra, Universidad de Navarra

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00530140