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NCT Number: NCT06823960

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.

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Key information

Conditions

Marginal Zone Lymphoma(MZL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of relapsed/refractory marginal zone lymphoma
  • 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

  • relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Broccoli, MD

CONTACT

[email protected]

+39 0512143680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+39 0512143680

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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)

Acronym: ZanOs

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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