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

Condition(s) studied

Investigational drug(s) / intervention(s)

"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

Study 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

Primary outcome measure(s)

• Overall response rate (ORR) — At least 5 years
  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).
• Complete Response rate (CRR) — At least 5 years
  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.
• Progression free survival (PFS) — At least 5 years
  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.
• Overall survival (OS) — At least 5 years
  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.
• Event free survival (EFS) — At least 5 years
  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.
• Time-to-next treatment (TTNT) — At least 5 years
  TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
• non-relapse mortality (NRM) — At least 5 years
  NRM is defined as death without recurrent or progressive disease after treatment.
• Duration of response (DOR) — At least 5 years
  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.
• Incidence of Early/Late Adverse Events — At least 5 years
  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.

Trial sites (61)

+ 21 more sites — see the full list on the official registry below.

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