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
Fondazione Italiana Linfomi - ETS
1,500 participants
Dec 27, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- Being involved in a prospective interventional trial outside indication.
- Patients treated outside approved indications:
- approved indication.
- % AIFA support.
- Compassionate use.
- Age less than 18 years.
- Inability to provide an informed consent.
Interventions
"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
Locations(61)
View Full Details on ClinicalTrials.gov
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NCT06008691