Clinical trial
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
Name
FIL_MAB
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2038-10-01
Trial end
2038-10-01
Status
Not yet recruiting
Treatment
"novel" MAB (alone or in combination)
"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
Arms:
B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
Size
1500
Primary endpoint
Overall response rate (ORR)
At least 5 years
Complete Response rate (CRR)
At least 5 years
Progression free survival (PFS)
At least 5 years
Overall survival (OS)
At least 5 years
Event free survival (EFS)
At least 5 years
Time-to-next treatment (TTNT)
At least 5 years
non-relapse mortality (NRM)
At least 5 years
Duration of response (DOR)
At least 5 years
Incidence of Early/Late Adverse Events
At least 5 years
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}
Updated at
2023-08-23
1 organization
Organization
Fondazione Italiana Linfomi