Idiotypic Vaccination for Follicular Lymphoma Patients (FLIDVAX2006)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Collaborators:
University of Navarrra Hospital (Clinica Universitaria)
Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00530140
First received: September 12, 2007
Last updated: October 5, 2011
Last verified: October 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Navarra Hospital Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: MAURIZIO BENDANDI, MD, PhD         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
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
  More Information

Publications:
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00530140     History of Changes
Other Study ID Numbers: CUN-90-2006
Study First Received: September 12, 2007
Last Updated: October 5, 2011
Health Authority: Spain: Ministry of Health
Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Follicular Lymphoma
Idiotype vaccine

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014