Clinical trial NCT00530140: Idiotypic Vaccination for Follicular Lymphoma Patients
Official title: Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Lymphoma
First Relapse/Progression
Keywords: Follicular Lymphoma
Idiotype vaccine
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: University of Navarrra Hospital (Clinica Universitaria)
name: Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
First posted: 2007-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
timeFrame: 15 years
Secondary outcomes:
measure: Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
timeFrame: 15 years
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra Hospital
state: Navarra
Study officials:
affiliation: University of Navarra
name: MAURIZIO BENDANDI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.