Clinical trial · Observational
Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines'-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance
- 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)
This is a prospective biological study evaluating the persistence of COVID-19 vaccine and other vaccines' (zoster, diphtheria and tetanus)-induced immunity in a subgroup patient affected by Follicular Lymphoma requiring treatment undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL\_FOLL19 study (NCT05058404). Blood samples from patients will be collected before and at planned timepoints during treatment to evaluate humoral and cellular immunity against SARS-COV-2, VZV, tetanus and diphtheria and T-cell markers characterization.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellular immunity vs SARS-CoV-2 | Diagnostic Test | — | UNRESOLVED |
| Cellular immunity vs Varicella Zoster Virus | Diagnostic Test | — | UNRESOLVED |
| Diphtheria toxin-binding IgG | Diagnostic Test | — | UNRESOLVED |
| Humoral immunity vs SARS-CoV-2 | Diagnostic Test | — | UNRESOLVED |
| Humoral immunity vs Varicella Zoster Virus | Diagnostic Test | — | UNRESOLVED |
| T-cell populations and markers characterization | Diagnostic Test | — | UNRESOLVED |
| Tetanus toxoid-binding IgG | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients enrolled
- description
- Patient affected by advanced Follicular Lymphoma undergoing front-line immunochemotherapy and antiCD-20 maintenance in the FIL\_FOLL19 trial
- interventionNames
- Diagnostic Test: Cellular immunity vs SARS-CoV-2
- Diagnostic Test: Humoral immunity vs SARS-CoV-2
- Diagnostic Test: Cellular immunity vs Varicella Zoster Virus
- Diagnostic Test: Humoral immunity vs Varicella Zoster Virus
- Diagnostic Test: Diphtheria toxin-binding IgG
- Diagnostic Test: Tetanus toxoid-binding IgG
- Diagnostic Test: T-cell populations and markers characterization
Primary outcomes (1)
- measure
- Rate of patients with persistence of cell-mediated immunity induced by COVID-19 approved vaccines (at least three doses) after standard induction immuno-chemotherapy.
- timeFrame
- At the end of induction therapy (EOI) - About 8 months from treatment start
- description
- Proportion of patients with laboratory parameters of vaccine-induced cellular immunity against SARS-CoV-2 (by ELISpot assay) at EOI (after induction immuno-chemotherapy) vs proportion at baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Enrolment in FIL\_FOLL19 study 2. Previous vaccination for COVID-19 (at least 3 doses) 3. Availability of informations about COVID-19 and other vaccines previously administered (vaccination records) 4. Willingness to comply with blood collection timepoints required for vaccination immunity evaluation 5. Signature of specific informed consent form Exclusion Criteria: None
References
Publications (0)
Data not yet available