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Idiotypic Vaccination for Follicular Lymphoma Patients (FLIDVAX2006)

Primary Purpose

Follicular Lymphoma, First Relapse/Progression

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular Lymphoma, Idiotype vaccine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Navarra HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

All patients will receive the same vaccination schedule/formulation

Outcomes

Primary Outcome Measures

Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)

Secondary Outcome Measures

Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame

Full Information

NCT ID

NCT00530140

First Posted

September 12, 2007

Last Updated

October 5, 2011

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

University of Navarrra Hospital (Clinica Universitaria), Center for Applied Medical Research (Centro de Investigación Médica Aplicada)

1. Study Identification

Unique Protocol Identification Number

NCT00530140

Brief Title

Idiotypic Vaccination for Follicular Lymphoma Patients

Acronym

FLIDVAX2006

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

University of Navarrra Hospital (Clinica Universitaria), Center for Applied Medical Research (Centro de Investigación Médica Aplicada)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma, First Relapse/Progression

Keywords

Follicular Lymphoma, Idiotype vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

All patients will receive the same vaccination schedule/formulation

Intervention Type

Biological

Intervention Name(s)

Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)

Time Frame

15 years

Secondary Outcome Measure Information:

Title

Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame

Time Frame

15 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MAURIZIO BENDANDI, MD, PhD

Phone

+34606002087

mbendandi@unav.es

First Name & Middle Initial & Last Name or Official Title & Degree

SUSANA INOGES, MD, PhD

Phone

+34685972257

sinoges@unav.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MAURIZIO BENDANDI, MD, PhD

Organizational Affiliation

University of Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Navarra Hospital

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MAURIZIO BENDANDI, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16985248

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.

Results Reference

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Idiotypic Vaccination for Follicular Lymphoma Patients

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