Status:
RECRUITING
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Non-Hodgkin Lymphoma, B-cell
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
This is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel MAB that ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2038
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06008691
Start Date
December 27 2023
End Date
October 1 2038
Last Update
December 29 2025
Active Locations (61)
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1
Istituto Oncologico del Mediterraneo SPA - Oncologico
Viagrande, Catania, Italy
2
Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
Pescia, Pistoia, Italy
3
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria, Italy
4
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy