Idiotypic Vaccination for Follicular Lymphoma Patients

Phase 2 Unknown 100 enrolled Clinica Universidad de Navarra, Universidad de Navarra Center for Applied Medical Research (Centro de Investigación Médica Aplicada) · collab University of Navarrra Hospital (Clinica Universitaria) · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2007-10
Primary completion: 2013-09
Completion: 2022-09

Publications

Background Inoges S, Rodriguez-Calvillo M, Zabalegui N, Lopez-Diaz de Cerio A, Villanueva H, Soria E, Suarez L, Rodriguez-Caballero A, Pastor F, Garcia-Munoz R, Panizo C, Perez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Espanol de Linfomas/Trasplante Autologo de Medula Oseo study group; Programa para el Estudio y Tratamiento de Hemopatias Malignas study group. Clinical benefit associated with idiotypic vaccination in patients with follicular lymphoma. J Natl Cancer Inst. 2006 Sep 20;98(18):1292-301. doi: 10.1093/jnci/djj358.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	patient-specific, soluble protein idiotype vaccine	Vaccine	0.5 mg	—
Background	GM-CSF	Protein / enzyme biologic	125 ug	—
Background	KLH	Unknown	0.5 mg	—

Idiotypic Vaccination for Follicular Lymphoma Patients

Summary

Timeline

Publications

Drugs

Indications