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Idiotypic Vaccination for Follicular Lymphoma Patients (FLIDVAX2006)

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ClinicalTrials.gov Identifier: NCT00530140
Recruitment Status : Recruiting
First Posted : September 17, 2007
Last Update Posted : October 6, 2011
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

Tracking Information
First Submitted Date  ICMJE September 12, 2007
First Posted Date  ICMJE September 17, 2007
Last Update Posted Date October 6, 2011
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured) [ Time Frame: 15 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00530140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame [ Time Frame: 15 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Idiotypic Vaccination for Follicular Lymphoma Patients
Official Title  ICMJE Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Lymphoma
  • First Relapse/Progression
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: A
All patients will receive the same vaccination schedule/formulation
Intervention: Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
Publications * Inogès S, Rodrìguez-Calvillo M, Zabalegui N, Lòpez-Dìaz de Cerio A, Villanueva H, Soria E, Suárez L, Rodríguez-Caballero A, Pastor F, García-Muñóz R, Panizo C, Pèrez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Español 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2007)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MAURIZIO BENDANDI, MD, PhD +34606002087 mbendandi@unav.es
Contact: SUSANA INOGES, MD, PhD +34685972257 sinoges@unav.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530140
Other Study ID Numbers  ICMJE CUN-90-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE
  • University of Navarrra Hospital (Clinica Universitaria)
  • Center for Applied Medical Research (Centro de Investigación Médica Aplicada)
Investigators  ICMJE
Principal Investigator: MAURIZIO BENDANDI, MD, PhD University of Navarra
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP