A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice

Study Overview
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Brief Summary
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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
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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 have received approval from EMA since 2020 and are prescribed according to the indications for use authorized for marketing in Italy. Patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. Additional sub-cohorts will be defined if needed. Final outputs will be based according to: Per indication analysis; Pooled analyses by type of antibody and subtype and other parameters; A general analysis of the whole cohort.

Official Title
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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
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Non-Hodgkin Lymphoma, B-cell

Intervention / Treatment
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* Drug: novel MAB (alone or in combination)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).<br>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. | Drug: novel MAB (alone or in combination)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | 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). | At least 5 years | 
| Complete Response rate (CRR) | CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders. | At least 5 years | 
| Progression free survival (PFS) | PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date. | At least 5 years | 
| Overall survival (OS) | OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date. | At least 5 years | 
| Event free survival (EFS) | ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression. | At least 5 years | 
| Time-to-next treatment (TTNT) | TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy. | At least 5 years | 
| non-relapse mortality (NRM) | NRM is defined as death without recurrent or progressive disease after treatment. | At least 5 years | 
| Duration of response (DOR) | DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria. | At least 5 years | 
| Incidence of Early/Late Adverse Events | Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly: Hematological and extra-hematological toxicities Grade > 2 Infusional adverse events, will be recorded any Grade Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade Early and toxic deaths and cause of any death. | At least 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin Lymphoma, B-cell, monoclonal antibodies, novel antibodies