Clinical trial · Interventional
Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab
Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab (EVAPOR Study)
- 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)
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).
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 |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Pneumococcal Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Single-dose before treatment
- description
- 12 patients will receive a single-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection
- interventionNames
- Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma
- type
- ACTIVE_COMPARATOR
- label
- Single-dose after treatment
- description
- 12 patients will receive a singe-dose of prevenar three weeks after the beginning of the immunochemotherapy (R-CHOP) following two months later by pneumovax injection
- interventionNames
- Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * De novo Diffuse Large B-Cell Lymphoma diagnostic (according 2016 World Health Organization (WHO) classification) * Treatment decision by immunochemotherapy (R-CHOP) * Age over 18 years old * Negative pregnancy test at inclusion * Active contraception at inclusion * Free and informed consent procedure at inclusion * Affiliation of the social security system Exclusion Criteria: * Patient with prior treatment by immunotherapy or chemotherapy * Patient with prior treatment by debulking chemotherapy (COP) * Patient with prior treatment by high-dose of corticosteroids * Patients with an autoimmune disease * Patients with a diffuse large B-cell lymphoma from transformation (follicular lymphoma, chronic lymphoid leukemia) * Immunosuppressed patient with : asplenia, hereditary immunodeficiency disorder, infection by HIV, hepatitis B or C viruses, transplanted patient, hematopoietic stem cell transplantation, nephrotic syndrome, meningeal breach, cochlear implants. * Patients vaccinated in the last month before inclusion * Patients with prior transfusion of blood-products or immunoglobulins in the last three months before inclusion * Patient with bleeding disorders or thrombopenia contraindicating intramuscular injection * Patient with prior pneumococcal documented infection * Patient with current pregnancy and/or breastfeeding * Patient under curatorship or guardianship
References
Publications (0)
Data not yet available