Clinical trial • Phase III • Oncology

ZANUBRUTINIB for Mantle cell lymphoma

Phase III trial of ZANUBRUTINIB for Mantle cell lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Mantle cell lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
16-04-2024
First CTIS Authorization Date
27-05-2024

Trial design

Randomised, open-label, zanubrutinib (oral capsule; active substance zanubrutinib; max daily dose listed 320 mg) plus rituximab (mabthera; active substance rituximab; intravenous concentrate; dose listed 375 mg/m2) versus bendamustine plus rituximab (bendamustine (hikma or kabi formulations) intravenous powder for concentrate; active substance bendamustine hydrochloride; dose listed 90 mg/m2; rituximab 375 mg/m2). schedule not specified in the available documents.-controlled Phase III trial in Romania, Italy, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Zanubrutinib (oral capsule; active substance zanubrutinib; max daily dose listed 320 mg) plus Rituximab (MabThera; active substance rituximab; intravenous concentrate; dose listed 375 mg/m2) versus Bendamustine plus Rituximab (Bendamustine (Hikma or Kabi formulations) intravenous powder for concentrate; active substance bendamustine hydrochloride; dose listed 90 mg/m2; Rituximab 375 mg/m2). Schedule not specified in the available documents.
Target Sample Size
251

Eligibility

Recruits 251 No vulnerable populations selected. Participants must have the ability to provide written informed consent (inclusion criterion: "Ability to provide written informed consent and ability to understand and comply with the requirements of the study"). Consent is provided by the participant; no assent procedures for minors are described..

Pregnancy Exclusion
Pregnant or lactating women
Vulnerable Population
No vulnerable populations selected. Participants must have the ability to provide written informed consent (inclusion criterion: "Ability to provide written informed consent and ability to understand and comply with the requirements of the study"). Consent is provided by the participant; no assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- ≥ 70 years of age at the time of informed consent, OR ≥ 60 and < 70 years of age with comorbidities precluding autologous stem cell transplantation including at least one of the following: a.\tCardiac ejection fraction (LVEF) ≤ 45% b.\tDiffusing capacity for carbon monoxide (DLCO) ≤ 60% predicted c.\tCreatinine clearance < 70 but ≥ 30 mL/min (if estimated by the Cockcroft-Gault equation, must be confirmed by nuclear medicine scan or 24-hour urine collection) d.\tEastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation e.\tCumulative Illness Rating Scale (CIRS) total score > 6 (Appendix 9)\n- Male patients are eligible if abstinent, vasectomized or if they agree to the use of barrier contraception in combination with other methods described in Section 5.3 during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib or 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.\n- Ability to provide written informed consent and ability to understand and comply with the requirements of the study\n- For all patients irrespective of their age, creatinine clearance of ≥ 30 mL/min determined by either: a.\tEstimation using the Cockcroft-Gault equation or b.\tMeasurement by nuclear medicine scan or 24 hour urine collection\n- Histologically confirmed diagnosis of MCL based on the World Health Organization 2016 classification of tumors of hematopoietic and lymphoid tissue (Swerdlow et al, 2016), including demonstration of positive cyclin D1 and/or t(11;14) a.\tFor patients enrolled in France only, MCL disease must be classified as Ann Arbor Stage II, III, or IV\n- No prior systemic treatments for MCL\n- Presence of measurable disease, defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter\n- Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy\n- ECOG performance status of 0, 1, or 2\n- Life expectancy of ≥ 3 months\n- Adequate organ function defined as: a.\tAbsolute neutrophil count (ANC) > 750/mm3 (without growth factor support within 7 days) For patients enrolled in the United Kingdom (UK) and Germany only, ANC must be > 1000/mm3 b.\tPlatelets > 75,000/mm3 (or ≥ 50,000/mm3 for patients with bone marrow involvement of lymphoma); without growth factor support or transfusion within 7 days c.\tAspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 3.0 × upper limit of normal (ULN) d.\tSerum total bilirubin ≤ 1.5 × ULN (unless documented Gilbert’s syndrome) For patients with Gilbert’s syndrome enrolled in the UK only, direct bilirubin must be ≤ 1 x ULN e.\tFor patients enrolled in the UK only, international normalized ratio (INR) < 1.5 for patients not receiving therapeutic anticoagulation; INR 2.0 to 3.0 for patients receiving therapeutic anticoagulation\n- Female patients of childbearing potential must practice highly effective methods of contraception (Section 5.3) initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib or bendamustine, or 12 months after the last dose of rituximab, whichever is longer."}

Exclusion criteria

  • {"criterion_text":"- Known central nervous system involvement by lymphoma\n- Active fungal, bacterial and/or viral infection requiring systemic therapy\n- Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results\n- Known infection with human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection as follows: a.\tPresence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU/mL), and if they are willing to undergo monitoring for HBV reactivation. b.\tPresence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.\n- Major surgery within 4 weeks of the first dose of study drug\n- Pregnant or lactating women\n- Vaccination with a live vaccine within 35 days prior to the first dose of study drug\n- Ongoing alcohol or drug addiction\n- Hypersensitivity to zanubrutinib, bendamustine, or rituximab or any of the other ingredients of the study drugs\n- Requires ongoing treatment with a strong CYP3A inhibitor or inducer (see Appendix 3)\n- Concurrent participation in another therapeutic clinical trial.\n- Prior hematopoietic stem cell transplantation\n- Patients enrolled in Germany only, who are severely immunocompromised.\n- Prior exposure to a BTK inhibitor, rituximab, or bendamustine\n- Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant\n- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer\n- Clinically significant cardiovascular disease including the following: a.\tMyocardial infarction within 6 months before Screening b.\tUnstable angina within 3 months before Screening c.\tNew York Heart Association class III or IV congestive heart failure (see Appendix 6) d.\tHistory of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) e.\tQTcF > 480 msecs based on Fridericia’s formula f.\tHistory of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place g.\tUncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mm Hg and diastolic blood pressure > 105 mm Hg at Screening\n- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is PFS as determined by independent central review using the Lugano Classification for NHL and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.","definition_or_measurement_approach":"Progression-free survival (PFS) determined by independent central review using the Lugano Classification for non-Hodgkin lymphoma; defined as time from randomization to first documentation of disease progression or death, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival as determined by investigator assessment using the Lugano Classification for NHL, and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first","definition_or_measurement_approach":"PFS determined by investigator assessment using Lugano Classification; time from randomization to documented progression or death."}
  • {"endpoint_text":"- Overall response rate, defined as the proportion of patients who achieve a CR or partial response (PR), determined by independent central review and by investigator assessment","definition_or_measurement_approach":"ORR = proportion achieving complete response (CR) or partial response (PR); assessed by independent central review and investigator assessment."}
  • {"endpoint_text":"- Duration of response, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first","definition_or_measurement_approach":"DOR = time from first meeting response criteria to objective documentation of progression or death; assessed by independent central review and investigator assessment."}
  • {"endpoint_text":"- Overall survival, defined as the time from randomization to the date of death due to any reason","definition_or_measurement_approach":"OS = time from randomization to death from any cause."}
  • {"endpoint_text":"- Rate of CR or complete metabolic response, defined as the proportion of patients who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment","definition_or_measurement_approach":"Proportion achieving CR or complete metabolic response; assessed by independent central review and investigator assessment."}
  • {"endpoint_text":"- Time to response, as determined by independent central review and by investigator assessment, and defined as time from randomization to the first documentation of response","definition_or_measurement_approach":"Time from randomization to first documented response; assessed by independent central review and investigator assessment."}
  • {"endpoint_text":"- Patient-reported outcomes as measured by the EQ-5D-5L and EORTC QLQ-C30 questionnaires","definition_or_measurement_approach":"PROs measured using EQ-5D-5L and EORTC QLQ-C30 questionnaires."}
  • {"endpoint_text":"- Safety parameters, including AEs, SAEs, clinical laboratory tests, physical exams, and vital signs","definition_or_measurement_approach":"Safety assessed by recording adverse events (AEs), serious adverse events (SAEs), clinical labs, physical examinations, and vital signs."}

Recruitment

Planned Sample Size
251
Recruitment Window Months
146
Consent Approach
Written informed consent required from each participant (inclusion criterion: "Ability to provide written informed consent and ability to understand and comply with the requirements of the study"). Multiple ICF documents and subject information sheets are available (Main ICF, Pregnant Partner ICF, Optional Research Sub Study ICF, Patient Discontinuation ICF, Storage and Optional Future Research ICF, and translations/versions for participating countries), indicating country- and language-specific ICF versions. No assent procedures for minors are described.

Geography

Total Number Of Sites
77
Total Number Of Participants
267

Romania

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
25-08-2025
Processing Time Days
480
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Hematology Clinic
Contact Person Name
Catalin Danaila
Contact Person Email
xxx@xxx.xx
Site Name
Institutul Clinic Fundeni
Department Name
Hematology Clinic
Contact Person Name
Mariana Vasilica
Contact Person Email
xxx@xxx.xx

Italy

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
476
Number Of Sites
13
Number Of Participants
56

Sites

Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Ematologia
Contact Person Name
Alberto Fabbri
Contact Person Email
fabbri7@unisi.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Ematologia
Contact Person Name
Gianluca Gaidano
Contact Person Email
gianluca.gaidano@med.uniupo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dipartimento di Medicina Traslazionale e di Precisione_Sezione Ematologia
Contact Person Name
Maurizio Martelli
Contact Person Email
martelli@bce.uniroma1.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Ematologia
Contact Person Name
Carola Boccomini
Site Name
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Department Name
Divisione di Ematologia
Contact Person Name
Manuela Zanni
Contact Person Email
manuela.zanni@ospedale.al.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
S.C. Ematologia
Contact Person Name
Carlo Visco
Contact Person Email
carlo.visco@univr.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
UOC di Ematologia
Contact Person Name
Stefano Luminari
Contact Person Email
stefano.luminari@ausl.re.it
Site Name
Azienda Ospedaliera Universitaria Pisana
Department Name
UO Ematologia
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@med.unipi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Ematologia
Contact Person Name
Vittorio Ruggero Zilioli
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ematologia
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
UO Ematologia I
Contact Person Name
Caterina Patti
Contact Person Email
k.patti@villasofia.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Ematologia
Contact Person Name
Adalberto Ibatici
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UO Ematologia
Contact Person Name
Pierluigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it

Austria

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
22-08-2025
Processing Time Days
477
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Innere Medizin I
Contact Person Name
Markus Raderer
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Innere Medizin III
Contact Person Name
Thomas Melchardt
Contact Person Email
t.melchardt@salk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
I. Interne Abteilung
Contact Person Name
Olga Saini
Contact Person Email
olga.saini@ordensklinikum.at

Portugal

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
475
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncohematology
Contact Person Name
Ângelo Martins
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Hematology
Contact Person Name
Maria Silva
Contact Person Email
maria.g.silva@netcabo.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Hematology and bone marrow transplantation
Contact Person Name
Ana Mata
Contact Person Email
anavagosmata@gmail.com

France

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
25-08-2025
Processing Time Days
455
Number Of Sites
13
Number Of Participants
44

Sites

Site Name
Institut Paoli-Calmettes
Department Name
Service hématologie
Contact Person Name
Jean-Marc Schiano de Colella
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Service hématologie
Contact Person Name
Lucie Oberic
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service hématologie
Contact Person Name
Rémy Gressin
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Service hématologie
Contact Person Name
Violaine Safar
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service hématologie
Contact Person Name
Adrian Tempescul
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Service hématologie
Contact Person Name
Kamel Laribi
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Curie
Department Name
Service hématologie
Contact Person Name
Steven Le Gouill
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service hématologie
Contact Person Name
Franck Morschhauser
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service hématologie
Contact Person Name
Vincent Delwail
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service hématologie
Contact Person Name
Thomas Gastinne
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Bergonie
Department Name
Service hématologie
Contact Person Name
Fontanet Bijou
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Service hématologie
Contact Person Name
Ronan Le Calloch
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service hématologie
Contact Person Name
Steeve Chevreux
Contact Person Email
xxxxxx@xxxxxxx.fr

Ireland

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
18-08-2025
Processing Time Days
473
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
St James's Hospital
Department Name
Haematology
Contact Person Name
Elisabeth Ann Vandenberghe
Contact Person Email
evandenberghe@stjames.ie
Site Name
University Hospital Galway
Department Name
Haematology
Contact Person Name
Amjad Hayat
Contact Person Email
Amjad.Hayat@hse.ie
Site Name
University Hospital Waterford
Department Name
Haematology
Contact Person Name
Ezzat Elhassadi
Contact Person Email
ezzat.elhassadi@hse.ie
Site Name
Cork University Hospital
Department Name
Haematology
Contact Person Name
Derville O'Shea
Contact Person Email
Derville.oshea@hse.ie
Site Name
University Hospital Limerick
Department Name
Haematology
Contact Person Name
Hilary O'Leary
Contact Person Email
HilaryM.OLeary@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Hematology
Contact Person Name
Anne Fortune
Contact Person Email
afortune@mater.ie

Germany

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
475
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Hämatologie, Onkologie und Rheumatologie
Contact Person Name
Isabelle Krämer
Site Name
Petrus-Krankenhaus
Department Name
Klinik für Innere Medizin III
Contact Person Name
Matthias Sandmann
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Innere Medizin III
Contact Person Name
Eugen Tausch
Contact Person Email
eugen.tausch@uniklinik-ulm.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Contact Person Name
Ron Jachimowicz
Contact Person Email
ron.jachimowicz@uk-koeln.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik III
Contact Person Name
Martin Heinz Dreyling

Spain

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
533
Number Of Sites
10
Number Of Participants
37

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Ana Marin Niebla
Contact Person Email
amarin@vhio.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Contact Person Name
Mariana Bastos Oreiro
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Contact Person Name
Victor Jimenez Yuste
Contact Person Email
vjyuste.ensayos@gmail.com
Site Name
MD Anderson Cancer Center
Department Name
Hematology
Contact Person Name
Adolfo de la Fuente Burguera
Contact Person Email
afuente@mdanderson.es
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Hematology
Contact Person Name
Juan Manuel Sancho Cia
Contact Person Email
jsancho@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Sergio Ramos
Contact Person Email
sergio.ramosc@quironsalud.com
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Hematology
Contact Person Name
Eva Gonzalez Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Contact Person Name
Fatima de la Cruz Vicente
Contact Person Email
fatimadelacruzv@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Hematology
Contact Person Name
Manuel Espeso de Haro
Contact Person Email
mespesoh@hotmail.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Hematology
Contact Person Name
Nicholas John Kelleher
Contact Person Email
nkelleher@iconcologia.net

Poland

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
533
Number Of Sites
10
Number Of Participants
61

Sites

Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
-
Contact Person Name
Hanna Ciepłuch
Contact Person Email
XX@XX
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddział Hematologii
Contact Person Name
Aleksandra Butrym
Site Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii Im. M. Kopernika w Łodzi
Department Name
-
Contact Person Name
Tadeusz Robak
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
-
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
emaranda@ihit.waw.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
-
Contact Person Name
Paweł Kiciński
Contact Person Email
XX@XX
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
Contact Person Name
Tomasz Wróbel
Contact Person Email
XX@XX
Site Name
Pratia Onkologia Katowice
Department Name
-
Contact Person Name
Sebastian Grosicki
Contact Person Email
XX@XX
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
-
Contact Person Name
Adam Witkowski
Contact Person Email
XX@XX
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Contact Person Name
Michał Taszner
Contact Person Email
XX@XX
Site Name
Pratia S.A.
Department Name
-
Contact Person Name
Wojciech Jurczak
Contact Person Email
XX@XX

Belgium

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
687
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Contact Person Name
Marie Lejeune
Contact Person Email
marie.lejeune@chuliege.be
Site Name
Antwerp University Hospital
Department Name
Hematology
Contact Person Name
Matthias Vanderkerken
Contact Person Email
iris.verhaegen@uza.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Hematology
Contact Person Name
Koen Van Eygen
Contact Person Email
koen.vaneygen@azgroeninge.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Contact Person Name
Gilles Crochet
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Contact Person Name
Sylvia Snauwaert
Contact Person Email
sylvia.snauwaert@azsintjan.be
Site Name
UZ Brussel
Department Name
Hematology
Contact Person Name
Veerle Beckers
Contact Person Email
Veerle.Beckers@uzbrussel.be

Netherlands

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
679
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Haga Hospital
Department Name
Hematology
Contact Person Name
Lara Bohmer
Contact Person Email
l.h.bohmer@hagaziekenhuis.nl
Site Name
Admiraal De Ruyter Ziekenhuis B.V.
Department Name
Hematology
Contact Person Name
Saskia Kuipers
Contact Person Email
s.s.kuipers@adrz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Contact Person Name
Jeanette Doorduijn
Contact Person Email
j.doorduijn@erasmusmc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Hematology
Contact Person Name
Harry Koene
Contact Person Email
h.koene@antoniusziekenhuis.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Contact Person Name
Eva De Jongh
Contact Person Email
wetenschap@asz.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Contact Person Name
Tom Van Meerten
Contact Person Email
t.van.meerten@umcg.nl

Sponsor

Primary sponsor

Full Name
BeOne Medicines AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
PPD (UK) Limited
Responsibilities
Drug safety (EC/IRB and investigator SUSAR reporting and Clinical Agregate reports submissions)
Name
Icon Clinical Research Limited
Name
Bioclinica Inc.
Responsibilities
Central scan overread and determination

Third parties

  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"Drug safety (EC/IRB and investigator SUSAR reporting and Clinical Agregate reports submissions)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"Routine clinical pathology testing","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"NeoGenomics Europe SA","duties_or_roles":"Routine clinical pathology testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Inivata Limited","duties_or_roles":"Routine clinical pathology testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Routine clinical pathology testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central scan overread and determination","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"PK samples","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Zanubrutinib
Active Substance
ZANUBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not authorised
Maximum Dose
320.00 mg (maxDailyDoseAmount)
Investigational Product Name
Bendamustin Hikma 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Active Substance
BENDAMUSTINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
90.00 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
MabThera 100 mg concentrate for solution for infusion
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised
Maximum Dose
375.00 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
Bendamustin Kabi 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Active Substance
BENDAMUSTINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
90.00 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
MabThera 500 mg concentrate for solution for infusion
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised
Maximum Dose
375.00 mg/m2 (maxDailyDoseAmount)
Combination Treatment
Yes

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