A Phase 2 interventional study of Follicular lymphoma, patient-specific, soluble protein idiotype vaccine in Follicular Lymphoma and First Relapse/Progression, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-10-06.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: at least one of the following:
Exclusion Criteria: any of the following:
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
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
Time frame: 15 years
Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
Time frame: 15 years
This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Clinica Universidad de Navarra, Universidad de Navarra