Clinical trial • Phase III • Oncology

N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY]BENZAMIDE for Mantle cell lymphoma (relapsed or refractory)

Phase III trial of N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-Y…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Mantle cell lymphoma (relapsed or refractory)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-12-2024
First CTIS Authorization Date
21-04-2025

Trial design

Randomised, two arms: sonrotoclax (bgb-11417) plus zanubrutinib versus bgb-11417 placebo plus zanubrutinib. products: sonrotoclax (bgb-11417) oral film-coated tablet (investigational product), bgb-11417 placebo, zanubrutinib oral capsule (comparator). specific dosing schedules not specified in the ctis metadata.-controlled Phase III trial in Austria, France, Germany and others.

Randomised
Yes
Comparator
Two arms: Sonrotoclax (BGB-11417) plus Zanubrutinib versus BGB-11417 placebo plus Zanubrutinib. Products: Sonrotoclax (BGB-11417) oral film-coated tablet (investigational product), BGB-11417 placebo, Zanubrutinib oral capsule (comparator). Specific dosing schedules not specified in the CTIS metadata.
Target Sample Size
160

Eligibility

Recruits 160 Vulnerable population selected. Subject information sheets and multiple informed consent forms are provided (including language-specific ICFs and specific ICFs titled e.g. "Pregnant Partner", "Optional Biopsies Research", "Optional Future Research", "Patient Discontinuation", "Treatment Through Progression"). Consent is to be obtained using these ICFs; trial documents indicate multiple language versions (German, Polish, Italian, Spanish, French, Slovenian among others). Participants are adults (paediatric subjects are excluded)..

Vulnerable Population
Vulnerable population selected. Subject information sheets and multiple informed consent forms are provided (including language-specific ICFs and specific ICFs titled e.g. "Pregnant Partner", "Optional Biopsies Research", "Optional Future Research", "Patient Discontinuation", "Treatment Through Progression"). Consent is to be obtained using these ICFs; trial documents indicate multiple language versions (German, Polish, Italian, Spanish, French, Slovenian among others). Participants are adults (paediatric subjects are excluded).

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHOHAEM5), or based on International Consensus Classification (ICC)\n- Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator\n- Relapsed or refractory disease after the last line of therapy\n- 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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n- Adequate organ function"}

Exclusion criteria

  • {"criterion_text":"- Prior therapy with B-cell lymphoma-2 inhibitor\n- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi\n- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n- Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug\n- Known central nervous system involvement by lymphoma\n- Clinically significant cardiovascular disease\n- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS), as assessed by blinded independent review committee (BIRC), defined as the time from randomization to the date of progression or death, whichever occurs first.","definition_or_measurement_approach":"Defined as the time from randomization to the date of progression or death, whichever occurs first; assessed by blinded independent review committee (BIRC)."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS), defined as the time from randomization to the date of death from any cause.","definition_or_measurement_approach":"Defined as the time from randomization to the date of death from any cause."}
  • {"endpoint_text":"- Progression-free survival (PFS) as determined by investigator.","definition_or_measurement_approach":"PFS determined by investigator assessment."}
  • {"endpoint_text":"- Overall response rate (ORR) as determined by BIRC and by investigator per the Lugano 2014 criteria. ORR is defined as the proportion of patients who achieved a best overall response of partial response or complete response (CR).","definition_or_measurement_approach":"ORR defined as proportion of patients with best overall response of partial response or complete response per Lugano 2014; assessed by BIRC and investigator."}
  • {"endpoint_text":"- Duration of response (DOR) as determined by BIRC and by investigator. It is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.","definition_or_measurement_approach":"DOR defined as time from first qualifying response to date of progression or death; assessed by BIRC and investigator."}
  • {"endpoint_text":"- Complete response rate (CRR), as determined by BIRC and by investigator. It is defined as the proportion of patients who achieved a best overall response of CR.","definition_or_measurement_approach":"CRR defined as proportion of patients achieving best overall response of CR; assessed by BIRC and investigator."}
  • {"endpoint_text":"- Time to first response as determined by BIRC and by investigator. It is defined as time from randomization to first response.","definition_or_measurement_approach":"Time from randomization to first response; assessed by BIRC and investigator."}
  • {"endpoint_text":"- Time to initiation of new anticancer therapy.","definition_or_measurement_approach":"Measured as time from randomization to initiation of new anticancer therapy."}
  • {"endpoint_text":"- Patient-reported symptom burden and physical condition/fatigue as measured by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29) questionnaire, and global health status (GHS) and physical function as measured by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC-QLQ-NHL-HG29 for symptom burden and EORTC-QLQ-C30 for global health status and physical function."}
  • {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events (TEAE)s graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0","definition_or_measurement_approach":"TEAEs graded per NCI-CTCAE v5.0; incidence and severity reported."}

Recruitment

Planned Sample Size
160
Recruitment Window Months
87
Consent Approach
Informed consent obtained via subject information sheets and informed consent forms (ICFs). Multiple language-specific ICFs and related documents are provided (document list includes ICFs and SIS in German, Polish, Italian, Spanish, French, Slovenian and others). Specific ICFs are provided for items such as Pregnant Partner, Optional Biopsies, Optional Future Research, Patient Discontinuation, and Treatment Through Progression. Consent is to be provided by adult participants (paediatric subjects excluded); no assent procedures for minors are indicated in the CTIS metadata.

Geography

Total Number Of Sites
30
Total Number Of Participants
140

Austria

Earliest CTIS Part Ii Submission Date
28-03-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
388
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
I. Interne Abteilung
Contact Person Name
Olga Saini
Site Name
Medical University Of Vienna
Department Name
Innere Medizin I
Contact Person Name
Markus Raderer
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Innere Medizin III
Contact Person Name
Alexander Egle
Contact Person Email
m.schachner@salk.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Innere Medizin I
Contact Person Name
Petra Pichler

France

Earliest CTIS Part Ii Submission Date
01-04-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
378
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hématologie clinique
Contact Person Name
Charles Herbaux
Contact Person Email
xxx@xxx.xx
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hématologie et thérapie cellulaire
Contact Person Name
Caroline Dartigeas
Contact Person Email
xxx@xxx.xx
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie clinique
Contact Person Name
Benoît Tessoulin
Contact Person Email
xxx@xxx.xx
Site Name
Hospices Civils De Lyon
Department Name
Hématologie clinique
Contact Person Name
Violaine Safar
Contact Person Email
xxx@xxx.xx

Germany

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
407
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Klinikum Chemnitz gGmbH
Department Name
Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Department of Medicine III
Contact Person Name
Martin Dreyling
Site Name
Goethe University Frankfurt
Department Name
Hämatologie/Medizinische Onkologie
Contact Person Name
Anne Wilke
Contact Person Email
a.wilke@med.uni-frankfurt.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Innere Medizin IV
Contact Person Name
Thomas Weber
Contact Person Email
thomas.weber@uk-halle.de
Site Name
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Department Name
Innere Medizin
Contact Person Name
Holger Hebart
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Judith Dierlamm
Contact Person Email
dierlamm@uke.de

Italy

Earliest CTIS Part Ii Submission Date
09-04-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
373
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Hematology
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Hematology
Contact Person Name
Carlo Visco
Contact Person Email
carlo.visco@univr.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Hematology
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Hematology
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Hematology
Contact Person Name
Francesco Zaja
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Hematology
Contact Person Name
Carlo Visco
Contact Person Email
carlo.visco@univr.it

Spain

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
382
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Eva Gine
Contact Person Email
EGINE@clinic.cat
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Eva Maria Gonzalez Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Sergio Tessoulin
Contact Person Email
xxx@xxx.xx
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Contact Person Name
Jose Antonio Garcia Vela
Contact Person Email
XXXX@XXXX

Poland

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
382
Number Of Sites
6
Number Of Participants
40

Sites

Site Name
Pratia S.A.
Contact Person Name
Wojciech Jurczak
Contact Person Email
rejestracja.mcm@pratia.com
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Contact Person Name
Jarosław Dybko
Contact Person Email
hematologia@dcopih.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogólnej i Chorób Wewnętrznych
Contact Person Name
Tadeusz Robak
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oddział Wieloprofilowy Zachowawczy
Contact Person Name
Krzysztof Giannopoulos
Contact Person Email
cwbk@umlub.pl
Site Name
Aidport Sp. z o.o.
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Pratia S.A.
Contact Person Name
Wojciech Jurczak
Contact Person Email
rejestracja.mcm@pratia.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Q Squared Solutions
Responsibilities
code:4
Name
PPD (UK) Limited
Responsibilities
code:8
Name
Iqvia Laboratories Limited
Responsibilities
code:4
Name
Medidata Solutions Inc.
Responsibilities
code:7
Name
ClinChoice, Inc.
Responsibilities
independent Data Monitoring Committee services
Name
Scout Clinical
Responsibilities
Reimbursement of patient expenses

Third parties

  • {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions","duties_or_roles":"code:4","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive","duties_or_roles":"Central imaging","organisation_type":"Industry"}
  • {"country":"China","full_name":"Sequanta Technologies Co. Ltd.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Beone Medicines USA Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"St James's University Hospital","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"ClinChoice, Inc.","duties_or_roles":"independent Data Monitoring Committee services","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Reimbursement of patient expenses","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
BGB-11417
Active Substance
N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3-NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY]BENZAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=1 (EU product record present)
Maximum Dose
320 mg (maxDailyDoseAmount: 320 mg)
Investigational Product Name
BGB-11417 placebo
Modality
Other
Investigational Product Name
Zanubrutinib
Active Substance
ZANUBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=1 (EU product record present)
Maximum Dose
320 mg (maxDailyDoseAmount: 320 mg)
Combination Treatment
Yes

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