Clinical trial · Observational
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice
NCT06008691CI-TRIAL-00099769FIL_MABrecruitingClinicalTrials.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)
This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.
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 |
|---|---|---|---|
| Non-Hodgkin Lymphoma, B-cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "novel" MAB (alone or in combination) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
- description
- B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy). Patients first-line and relapsed or refractory who had received at least 1 dose of MAB. Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.
- interventionNames
- Drug: "novel" MAB (alone or in combination)
Primary outcomes (9)
- measure
- Overall response rate (ORR)
- timeFrame
- At least 5 years
- description
- ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).
- measure
- Complete Response rate (CRR)
- timeFrame
- At least 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory. * Patients aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy. * Signed written informed consent. Exclusion Criteria: * Being involved in a prospective interventional trial outside indication. * Patients treated outside approved indications: * 648-approved indication. * 5% AIFA support. * Compassionate use. * Age less than 18 years. * Inability to provide an informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.