Marginal Zone Lymphoma(MZL)
Conditions
Keywords
zanubrutinib
Brief summary
Observational, non-interventional, retrospective, multicentre study focusing on efficacy and safety of zanubrutinib in daily clinical practice in patients with relapsed/refractory (R/R) marginal zone lymphoma.
Detailed description
Due to the rarity of the condition and the novelty of its application, the study is intended to be exploratory, with the aim of providing interim evidence on which to plan future studies in larger populations. Data will be collected from the start of therapy until 6 months after the end of therapy, when applicable.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma 2. Patients who received at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023 3) Age≥18 at start of zanubrutinib therapy. 4) Signature of written informed consent to study participation and personal data processing.
Exclusion criteria
1\) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | through the duration of study, an average of 6 months | the sum of the Complete Response \[CR\] and Partial Response \[PR\]) in accordance with the Lugano Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | through the duration of study, an average of 6 months | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
| Overall Survival (OS) | through the duration of study, an average of 6 months | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
| Duration of response (DoR) | through the duration of study, an average of 6 months | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
| Disease Free Survival (DFS) | through the duration of study, an average of 6 months | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
| Type, incidence, severity of any adverse events (AE) | from start of treatment to 30 days after last dose | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
| Best response rate (BRR), | through the duration of study, an average of 6 months | To evaluate safety and tollerability of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under Named patient program |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactAlessandro Broccoli, MD
Outcome results
None listed