Clinical trial · Interventional
Idiotypic Vaccination for Follicular Lymphoma Patients
Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First Relapse/Progression | — | UNRESOLVED | — |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follicular lymphoma, patient-specific, soluble protein idiotype vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- All patients will receive the same vaccination schedule/formulation
- interventionNames
- Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine
Primary outcomes (1)
- measure
- Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
- timeFrame
- 15 years
Secondary outcomes (1)
- measure
- Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame
- timeFrame
- 15 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDInoges 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. PMID 16985248