Marginal Zone Lymphoma(MZL)ZanOsNCT06823960
Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)
An observational study of Marginal Zone Lymphoma(MZL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 15 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma(MZL)
- How many people
- 59 participants
- Where
- 15 sitesItaly
- Study dates
- 9 Dec 2024to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Italy15 sites, 15 recruiting
- Not yet recruiting
AOU SS Antonio e Biagio e Cesare Arrigo
Alessandria, Alessandria, 15121
Gioacchino Catania, MD, +39 0131207825, gioacchino.catania@ospedale.al.it
Gioacchino Catania
- Not yet recruiting
IRCCS-AOU di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +39 0512143680, pierluigi.zinzani@unibo.it
Alessandro Broccoli, MD, +39 0512143680, alessandro.broccoli6@unibo.it
- Not yet recruiting
P.O. Garibaldi-Nesima_UOC Ematologia
Catania, Catania, 95122
Ugo Consoli, MD, +39 0957595801, uconsoli@arnasgaribaldi.it
Ugo Consoli, MD
- Not yet recruiting
AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia
Cosenza, Cosenza, 87100
Massimo Gentile, MD, +39 098421180, m.gentile@aocs.it
MAssimo Gentile, MD
- Not yet recruiting
AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche
Ferrara, Ferrara, 44124
Giulia Daghia, MD, +39 0532236092, giulia.daghia@ospfe.it
Giulia Daghia, MD
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola, Forlì Cesena, 47017
Francesco Malaspina, MD, +39 0543739100, francesco.malaspina@irst.emr.it
Francesco Malaspina, MD
- Not yet recruiting
Istituto Clinico Humanitas IRCCS - UO Ematologia
Milan, Milano, 20089
Massimo Magagnoli, 39 0282244533, massimo.magagnoli@humanitas.it
Massimo Magagnoli, MD
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia
Milan, MIlano, 20162
Marina Deodato, MD, 02 6444.2668, marina.deodato@ospedaleniguarda.it
Marina Deodato, MD
- Not yet recruiting
IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1
Padova, Padova, 35128
Dario Marino, MD, +39 0498215953, dario.marino@iov.veneto.it
Daio Marino, MD
- Not yet recruiting
Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico
Palermo, Palermo, 90146
Caterina Patti, MD, +39 0916802642, k.patti@villasofia.it
Caterina Patti, MD
- Not yet recruiting
Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna
Ravenna, Ravenna, 48121
MOnica Tani, +39 0544 285752, monica.tani@auslromagna.it
Monica Tani, MD
- Not yet recruiting
Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative
Roma, Roma, 00133
Vito Mario Rapisarda, MD, +39 06 20903224, gruppoarcobaleno@ptvonline.it
Vito Mario Rapisarda, MD
- Not yet recruiting
AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia
Torino, Torino, 10126
Candida Vitale, MD, +39 0116331442, candida.vitale@unito.it
Candida Vitale
- Not yet recruiting
Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina
Treviso, Treviso, 31100
Endri Mauro, +39 0422322221, endri.mauro@aulss2.veneto.it
Endri Mauro, MD
- Not yet recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia
Trieste, Trieste, 34128
Elisa Lucchini, MD, +39 0403992888, elisa.lucchini@asugi.sanita.fvg.it
Elisa Lucchini, MD
About this study
Official 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)
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.
Read the 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.
- Conditions
- Marginal Zone Lymphoma(MZL)
- Keywords
- zanubrutinib
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
the sum of the Complete Response [CR] and Partial Response [PR]) in accordance with the Lugano Classification
Measured: through the duration of study, an average of 6 months
Secondary outcomes (6)
Duration of response (DoR)
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
Measured: through the duration of study, an average of 6 months
Progression Free Survival (PFS)
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
Measured: through the duration of study, an average of 6 months
Overall Survival (OS)
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
Measured: through the duration of study, an average of 6 months
Best response rate (BRR),
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
Measured: through the duration of study, an average of 6 months
Disease Free Survival (DFS)
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
Measured: through the duration of study, an average of 6 months
Type, incidence, severity of any adverse events (AE)
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
Measured: from start of treatment to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Dec 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone Lymphoma(MZL)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823960
- Sponsor's protocol ID
- ZanOs
- Acronym
- ZanOs
- Status last verified
- Dec 2024
- First submitted
- 3 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06823960
- Acronym / sponsor ID
- ZanOs / ZanOs
- Conditions
- Marginal Zone Lymphoma(MZL)
- Keywords
- zanubrutinib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Duration of response (DoR)
Time frame: 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
Overall Survival (OS)
Time frame: 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
Disease Free Survival (DFS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Marginal Zone Lymphoma(MZL)
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Active, not recruitingPhase 2
PET/CT-Guided Maintenance Therapy in Previously Untreated MZL
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Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marginal Zone Lymphoma(MZL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+39 0512143680, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: through the duration of study, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.