Study to Assess Effectiveness and Safety of Zanubrutinib for Patients with Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP) (ZanOs)

February 11, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Zanubrutinib for Patients with Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Not yet recruiting
        • AOU SS Antonio e Biagio e Cesare Arrigo
        • Contact:
        • Contact:
          • Gioacchino Catania
      • Bologna, Italy, 40138
      • Catania, Italy, 95122
        • Not yet recruiting
        • P.O. Garibaldi-Nesima_UOC Ematologia
        • Contact:
          • Ugo Consoli, MD
        • Contact:
      • Cosenza, Italy, 87100
        • Not yet recruiting
        • AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia
        • Contact:
          • MAssimo Gentile, MD
        • Contact:
      • Ferrara, Italy, 44124
        • Not yet recruiting
        • AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche
        • Contact:
          • Giulia Daghia, MD
        • Contact:
      • Milano, Italy, 20089
        • Not yet recruiting
        • Istituto Clinico Humanitas IRCCS - UO Ematologia
        • Contact:
        • Contact:
          • Massimo Magagnoli, MD
      • Milano, Italy, 20162
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia
        • Contact:
        • Contact:
          • Marina Deodato, MD
      • Padova, Italy, 35128
        • Not yet recruiting
        • IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1
        • Contact:
        • Contact:
          • Daio Marino, MD
      • Palermo, Italy, 90146
        • Not yet recruiting
        • Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico
        • Contact:
          • Caterina Patti, MD
        • Contact:
      • Ravenna, Italy, 48121
        • Not yet recruiting
        • Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna
        • Contact:
          • Monica Tani, MD
        • Contact:
      • Roma, Italy, 00133
        • Not yet recruiting
        • Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative
        • Contact:
        • Contact:
          • Vito Mario Rapisarda, MD
      • Torino, Italy, 10126
        • Not yet recruiting
        • AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia
        • Contact:
        • Contact:
          • Candida Vitale
      • Treviso, Italy, 31100
        • Not yet recruiting
        • Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina
        • Contact:
        • Contact:
          • Endri Mauro, MD
      • Trieste, Italy, 34128
        • Not yet recruiting
        • Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia
        • Contact:
        • Contact:
          • Elisa Lucchini, MD
    • Forlì Cesena
      • Meldola, Forlì Cesena, Italy, 47017
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
        • Contact:
        • Contact:
          • Francesco Malaspina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsed/refractory marginal zone lymphoma treated with at least one dose of zanubrutinib under the Named patient program (D.M. 7 Sep 2017), between January 2021 and October 2023.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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
through the duration of study, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DoR)
Time Frame: 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
through the duration of study, an average of 6 months
Progression Free Survival (PFS)
Time Frame: 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
through the duration of study, an average of 6 months
Overall Survival (OS)
Time Frame: 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
through the duration of study, an average of 6 months
Best response rate (BRR),
Time Frame: 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
through the duration of study, an average of 6 months
Disease Free Survival (DFS)
Time Frame: 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
through the duration of study, an average of 6 months
Type, incidence, severity of any adverse events (AE)
Time Frame: 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
from start of treatment to 30 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZanOs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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