Idiotypic Vaccination for Follicular Lymphoma Patients

Phase 2

• Conditions: Follicular Lymphoma; First Relapse/Progression
• Interventions: Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

• Registration Number: NCT00530140
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Timeline

• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Study Start: 2007-10
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06
• Primary Completion: 2013-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Follicular lymphoma, patient-specific, soluble protein idiotype vaccine	All patients will receive the same vaccination schedule/formulation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Navarra Hospital; 🇪🇸 Pamplona, Navarra, Spain