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Idiotypic Vaccination for Follicular Lymphoma Patients
Conditions
Follicular Lymphoma - First Relapse/Progression
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Follicular Lymphoma, Idiotype vaccine
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
University of Navarra Hospital
Pamplona, Navarra, Spain
Status: Recruiting
Start Date
October 2007
Completion Date
September 2022
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Source
Clinica Universidad de Navarra, Universidad de Navarra
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page