Idiotypic Vaccination for Follicular Lymphoma Patients - Full Text View

Sponsors and Collaborators:	University of Navarre University of Navarrra Hospital (Clinica Universitaria) Center for Applied Medical Research
Information provided by:	University of Navarre
ClinicalTrials.gov Identifier:	NCT00530140

Purpose

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.

Condition	Intervention	Phase
Follicular Lymphoma First Relapse/Progression	Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Idiotypic Vaccination for Poor-Prognosis Follicular Lymphoma Patients in First Relapse

Further study details as provided by University of Navarre:

Primary Outcome Measures:

Percentage of patients who both never relapse and have a second complete response longer than their first response (cured) [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2022
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental All patients will receive the same vaccination schedule/formulation	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

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530140

Contacts

Contact: MAURIZIO BENDANDI, MD, PhD	+34606002087	mbendandi@unav.es
Contact: SUSANA INOGES, MD, PhD	+34685972257	sinoges@unav.es

Locations

Spain, Navarra
University of Navarra Hospital	Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: MAURIZIO BENDANDI, MD, PhD

Sponsors and Collaborators

University of Navarre

University of Navarrra Hospital (Clinica Universitaria)

Center for Applied Medical Research

Investigators

Principal Investigator:

MAURIZIO BENDANDI, MD, PhD

Hospital of Navarra

More Information

Publications:

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.

Responsible Party:	University of Navarra Hospital ( Maurizio Bendandi )
Study ID Numbers:	CUN-90-2006
Study First Received:	September 12, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00530140
Health Authority:	Spain: Department of Health - Government of Navarra; Spain: Spanish Agency of Medicines

Keywords provided by University of Navarre:

Follicular Lymphoma
Idiotype vaccine

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Disease Progression
Lymphoma, Follicular

Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009