Idiotypic Vaccination for Follicular Lymphoma Patients (FLIDVAX2006)

University of Navarra

Status and phase: Unknown; Phase 2

Conditions: First Relapse/Progression; Follicular Lymphoma

Treatments: Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00530140

CUN-90-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

A

Experimental group

Description:

All patients will receive the same vaccination schedule/formulation

Treatment:

Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine