Idiotypic Vaccination for Follicular Lymphoma Patients (FLIDVAX2006)

October 5, 2011 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MAURIZIO BENDANDI, MD, PhD
  • Phone Number: +34606002087
  • Email: mbendandi@unav.es

Study Contact Backup

  • Name: SUSANA INOGES, MD, PhD
  • Phone Number: +34685972257
  • Email: sinoges@unav.es

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
Time Frame: 15 years
15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
Time Frame: 15 years
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

Investigators

  • Principal Investigator: MAURIZIO BENDANDI, MD, PhD, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 5, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUN-90-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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