Idiotypic Vaccination for Follicular Lymphoma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Follicular Lymphoma, First Relapse/Progression

Intervention / Treatment
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* Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>All patients will receive the same vaccination schedule/formulation | Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Lymphoma, Idiotype vaccine