Clinical trial · Interventional
Phase II Cancer Vaccine Trial for Patients With Follicular Lymphoma
Radiotherapy Combined With Intratumoral Injections of Dendritic Cells and Rituximab - a Phase II Cancer Vaccine Trial for Patients With Untreated and Relapsed Indolent Non-Hodgkin's Lymphoma
NCT01926639CI-TRIAL-00015892Lymvac-1completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Patients with non-curable disseminated follicular lymphoma receive local radiotherapy targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to induce tumor immunity and clinical responses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy, rituximab and DC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy , rituximab and DC
- description
- Treatment repeated 3 times and targeting different lymph nodes
- interventionNames
- Biological: Radiotherapy, rituximab and DC
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 5 years
- description
- Clinical response measured by CT and PET/CT and immune response
Secondary outcomes (1)
- measure
- Immune response
- timeFrame
- 1 year
- description
- Immune response measured by flow cytometry. Peripheral blood mononuclear cells before and after treatment are cultures along with autologous tumor cells. Proliferation is measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years and older 2. Histologically confirmed (by WHO classification) untreated and relapsed indolent non-Hodgkin's B-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes. 3. Stage III/IV 4. Adequate bone marrow function (leukocyte count\>2,0, neutrophil count\>1.0, platelets\>50) 5. Two or more separate lymph nodes \> 1,5 cm available for biopsy or treatment. 6. Measurable disease present other than biopsy site and injection site(s). 7. Required wash-out period after previous treatment: Chemotherapy - 8 weeks, Radiotherapy - 4 weeks, Rituximab - 12 weeks 8. WHO status 0-1 9. Life expectancy of more than 6 months 10. Written informed consent 11. Able to comply with the treatment protocol - Exclusion Criteria: 1. Patients with progressive lymphoma in need of systemic therapy or standard dose irradiation. 2. Chronic bacterial, viral or fungal infection 3. Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease. 4. Known history of HIV 5. Central nervous system involvement of lymphoma 6. Current anticoagulant therapy which can not safely be paused during treatment injections (ASA \< 325 mg/day allowed) 7. Pregnancy -
References
Publications (1)
- DERIVEDKolstad A, Kumari S, Walczak M, Madsbu U, Hagtvedt T, Bogsrud TV, Kvalheim G, Holte H, Aurlien E, Delabie J, Tierens A, Olweus J. Sequential intranodal immunotherapy induces antitumor immunity and correlated regression of disseminated follicular lymphoma. Blood. 2015 Jan 1;125(1):82-9. doi: 10.1182/blood-2014-07-592162. Epub 2014 Oct 7. PMID 25293773