Idiotypic Vaccination for Follicular Lymphoma Patients

Follicular Lymphoma Clinical Trial

— FLIDVAX2006  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00530140
• Other study ID #: CUN-90-2006
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2007
• Last updated: October 5, 2011
• Start date: October 2007
• Est. completion date: September 2022

Study information

• Verified date: October 2011
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: MAURIZIO BENDANDI, MD, PhD
• Phone: +34606002087
• Email: mbendandi[@]unav.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• First Relapse/Progression
• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

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

Locations

Country	Name	City	State
Spain	University of Navarra Hospital	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Center for Applied Medical Research (Centro de Investigación Médica Aplicada), University of Navarrra Hospital (Clinica Universitaria)

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Inogès S, Rodrìguez-Calvillo M, Zabalegui N, Lòpez-Dìaz de Cerio A, Villanueva H, Soria E, Suárez L, Rodríguez-Caballero A, Pastor F, García-Muñóz R, Panizo C, Pèrez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Español 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)		15 years	No
Secondary	Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame		15 years	No