NCT00530140

Idiotypic Vaccination for Follicular Lymphoma Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma
• First Relapse/Progression

Interventions

Type	Name	Description
BIOLOGICAL	Follicular 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

Timeline

• Start date: 2007-10-01
• Primary completion: 2013-09-01
• Completion: 2022-09-01
• First posted: 2007-09-17
• Last updated: 2011-10-06

Locations

1 site across 1 country: Spain