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| Name | Class |
|---|---|
| University of Navarrra Hospital (Clinica Universitaria) | OTHER |
| Center for Applied Medical Research (Centro de Investigación Médica Aplicada) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | All patients will receive the same vaccination schedule/formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follicular lymphoma, patient-specific, soluble protein idiotype vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who both never relapse and have a second complete response longer than their first response (cured) | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame | 15 years |
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Inclusion Criteria: at least one of the following:
Exclusion Criteria: any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MAURIZIO BENDANDI, MD, PhD | Contact | +34606002087 | mbendandi@unav.es | |
| SUSANA INOGES, MD, PhD | Contact | +34685972257 | sinoges@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| MAURIZIO BENDANDI, MD, PhD | University of Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Navarra Hospital | Recruiting | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16985248 | Background | Inoges S, Rodriguez-Calvillo M, Zabalegui N, Lopez-Diaz de Cerio A, Villanueva H, Soria E, Suarez L, Rodriguez-Caballero A, Pastor F, Garcia-Munoz R, Panizo C, Perez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Espanol 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. doi: 10.1093/jnci/djj358. |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |