Idiotypic Vaccination for Follicular Lymphoma Patients

NCT ID: NCT00530140

Last Updated: 2011-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2022-09-30

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.

Conditions

Follicular Lymphoma; First Relapse/Progression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

All patients will receive the same vaccination schedule/formulation

Group Type: EXPERIMENTAL

Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Navarrra Hospital (Clinica Universitaria)

OTHER

Sponsor Role: collaborator

Center for Applied Medical Research (Centro de Investigación Médica Aplicada)

UNKNOWN

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MAURIZIO BENDANDI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Locations

University of Navarra Hospital

Pamplona, Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

MAURIZIO BENDANDI, MD, PhD

Role: CONTACT

mbendandi@unav.es

+34606002087

SUSANA INOGES, MD, PhD

Role: CONTACT

sinoges@unav.es

+34685972257

References

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.

Reference Type: BACKGROUND

PMID: 16985248 (View on PubMed)

Other Identifiers

CUN-90-2006

Identifier Type: -

Identifier Source: org_study_id