NCT04214444CompletedPhase 3
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 · Last updated 12 Feb 2026
Brief summary (registry, in English)
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%).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 24 Dec 2019
- Start date
- 3 Jul 2020
- Primary completion date
- 14 May 2024
- Lead sponsor
- University Hospital, Tours
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04214444
- EudraCT number
- 2019-002542-20
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 26
- From 3 Jul 2020 to the primary completion date, 14 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 prior pneumococcal documented infection
Other illness
- Patients with an autoimmune disease
- 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.
- Patient with bleeding disorders or thrombopenia contraindicating intramuscular injection
Other
- Patients with a diffuse large B-cell lymphoma from transformation (follicular lymphoma, chronic lymphoid leukemia)
- Patient with current pregnancy and/or breastfeeding
- Patient under curatorship or guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GYAN Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.