Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through the duration of study, an average of 6 months |
| Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) relapsed/refractory marginal zone lymphoma patients who received zanubrutinib in a clinical trial context.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pier Luigi Zinzani, MD | Contact | +39 0512143680 | pierluigi.zinzani@unibo.it | |
| Alessandro Broccoli, MD | Contact | +39 0512143680 | alessandro.broccoli6@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Pier Luigi Zinzani, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU SS Antonio e Biagio e Cesare Arrigo | Not yet recruiting | Alessandria | Alessandria | 15121 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) | 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), | 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) | 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) | 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 |
| IRCCS-AOU di Bologna | Not yet recruiting | Bologna | Bologna | 40138 | Italy |
|
| P.O. Garibaldi-Nesima_UOC Ematologia | Not yet recruiting | Catania | Catania | 95122 | Italy |
|
| AO di Cosenza, P.O. "Annunziata" - UOC di Ematologia | Not yet recruiting | Cosenza | Cosenza | 87100 | Italy |
|
| AOU di Ferrara_ UO di Ematologia - Dipartimento di Oncologia e Medicine Specialistiche | Not yet recruiting | Ferrara | Ferrara | 44124 | Italy |
|
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS | Recruiting | Meldola | Forlì Cesena | 47017 | Italy |
|
| Istituto Clinico Humanitas IRCCS - UO Ematologia | Not yet recruiting | Milan | Milano | 20089 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda _ UOC Ematologia | Not yet recruiting | Milan | MIlano | 20162 | Italy |
|
| IOV - Istituto Oncologico Veneto - IRCCS _UOC Oncologia1 | Not yet recruiting | Padova | Padova | 35128 | Italy |
|
| Ospedali Riuniti Villa Sofia - Cervello _ UO di Ematologia ad Indirizzo Oncologico | Not yet recruiting | Palermo | Palermo | 90146 | Italy |
|
| Ospedale Santa Maria delle Croci- OU Ematologia di Ravenna | Not yet recruiting | Ravenna | Ravenna | 48121 | Italy |
|
| Fondazione PTV Policlinico Tor Vergata- U.O.C. Patologie Linfoproliferative | Not yet recruiting | Roma | Roma | 00133 | Italy |
|
| AOU Città della Salute e della Scienza, "Le Molinette" - Divisione di Ematologia | Not yet recruiting | Torino | Torino | 10126 | Italy |
|
| Ospedale Ca' Foncello, Azienda ULSS n. 2 Marca trevigiana - UOC Ematologia Dipartimento di Medicina | Not yet recruiting | Treviso | Treviso | 31100 | Italy |
|
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale Maggiore- SC (UCO) Ematologia | Not yet recruiting | Trieste | Trieste | 34128 | Italy |
|
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided