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 Chronic lymphocytic leukemia (relapsed/refractory) | Small lymphocytic lymphoma (relapsed/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
Chronic lymphocytic leukemia (relapsed/refractory) | Small lymphocytic lymphoma (relapsed/refractory)
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
11-06-2025
First CTIS Authorization Date
26-09-2025

Trial design

Randomised, open-label, arms include: arm d (comparator): venetoclax plus rituximab (venetoclax + rituximab). other arms: sonrotoclax (bgb-11417) plus obinutuzumab; sonrotoclax plus rituximab; sonrotoclax plus obinutuzumab mrd-guided. doses/schedules are not specified in the provided data.-controlled, adaptive Phase III trial in Austria, Belgium, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Arms include: Arm D (comparator): Venetoclax plus Rituximab (venetoclax + rituximab). Other arms: Sonrotoclax (BGB-11417) plus Obinutuzumab; Sonrotoclax plus Rituximab; Sonrotoclax plus Obinutuzumab MRD-guided. Doses/schedules are not specified in the provided data.
Adaptive
True, MRD-guided treatment duration in Arm C (sonrotoclax plus obinutuzumab MRD-guided) is specified as an adaptive element; BIRC assessment applicability differences across arms are specified. No detailed interim analysis rules or stopping rules provided in the available data.
Target Sample Size
344

Eligibility

Recruits 344 No vulnerable population selected (isVulnerablePopulationSelected = false). Participants must be aged ≥ 18 years and provide informed consent; subject information sheets and informed consent forms are provided (multiple language versions). No assent procedures for minors are described..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected = false). Participants must be aged ≥ 18 years and provide informed consent; subject information sheets and informed consent forms are provided (multiple language versions). No assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Patients aged ≥ 18 years with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria (Hallek et al 2018).\n- Patients must have ≥ 1 prior therapy for CLL/SLL. For each line of therapy, patients must receive at least 2 cycles of this therapy.\n- For patients who received a BCL2i, only those with CLL/SLL who received BCL2i in the first line setting with fixed duration therapy, have a remission for ≥ 3 years, and have a time interval of ≥ 2 years from the last dose of BCL2i to screening, are eligible. Patients should be informed about their options to choose other approved CLL/SLL therapies in this setting.\n- Indications for CLL/SLL therapy are met by one of the criteria per the iwCLL 2018 criteria, with minor modification as discussed in the main protocol.\n- Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2.\n- Adequate marrow function as defined by: – Absolute neutrophil count ≥ 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case the absolute neutrophil count must be ≥ 0.75 x 109 cells/L (without growth factor support within the past 7 days). – Platelet counts ≥ 75 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), the platelet count should be ≥ 30 x 109 cells/L (without growth factor support or transfusion within the past 7 days). – Hemoglobin > 75 g/L (may be posttransfusion).\n- Adequate liver function as indicated by aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limits of normal (ULNs) value; serum total bilirubin ≤ 1.5 x ULNs (unless documented Gilbert syndrome where total bilirubin ≤ 3 x ULNs).\n- Adequate renal function, defined by a value ≥ 30 mL/min, determined either by creatinine clearance directly measured with a 24-hour urine collection or via estimated glomerular filtration rate calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation.\n- Life expectancy > 6 months."}

Exclusion criteria

  • {"criterion_text":"- No active infection including hepatitis B or C virus or HIV at the time of study treatment initiation.\n- No active prolymphocytic leukemia or currently suspected Richter’s transformation at the time of consideration for study.\n- No ongoing clinically significant cardiovascular or pulmonary disease that prevents participation.\n- No central nervous system involvement by CLL/SLL.\n- No history of prior or active malignancy within 18 months, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy: – Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. – Adequately treated cervical carcinoma in situ without evidence of disease. – Localized prostate cancer with Gleason score ≤ 6 or controlled prostate cancer with androgen deprivation treatment. – Treated early-stage breast cancer with or without hormonal therapy.\n- No other active antineoplastic treatment.\n- No CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS, defined as the time from the date of randomization to the date of disease progression as determined by the blinded independent review committee (BIRC) or death, whichever occurs first.","definition_or_measurement_approach":"Defined and measured as time from randomization to disease progression as determined by the Blinded Independent Review Committee (BIRC) or death, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- PFS, defined as the time from the date of randomization to the date of disease progression as determined by the BIRC or death, whichever occurs first.","definition_or_measurement_approach":"Same PFS definition; measured by BIRC or death."}
  • {"endpoint_text":"- • Undetectable minimal residual disease at < 10-4 sensitivity (uMRD4) rate in peripheral blood at C14D1 Visit based on next-generation sequencing (NGS [clonoSEQ]). • Complete response rate (CRR), defined as the proportion of patients that achieve a best response of CR or CRi (CR/CRi), as determined by the BIRC. • OS, defined as the time from the date of randomization to the date of death.","definition_or_measurement_approach":"uMRD4 assessed by NGS (clonoSEQ) at C14D1; CRR determined by BIRC (CR/CRi); Overall survival measured as time from randomization to death."}
  • {"endpoint_text":"- • PFS per investigator assessment. • CRR per the BIRC and investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and Posttreatment follow-up [PTFU]1) based on NGS (clonoSEQ).","definition_or_measurement_approach":"Investigator-assessed PFS and CRR; OS as time to death; uMRD4 rates assessed by NGS (clonoSEQ) at listed timepoints."}
  • {"endpoint_text":"- • PFS per BIRC and investigator assessment. • CRR per BIRC and investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and PTFU1) based on NGS (clonoSEQ).","definition_or_measurement_approach":"PFS and CRR assessed by both BIRC and investigator; OS time-to-death; uMRD4 by NGS (clonoSEQ)."}
  • {"endpoint_text":"- • Rate of uMRD4 (C8D1, C11D1 and PTFU1) based on NGS (clonoSEQ). • CRR per investigator assessment. • PFS per investigator assessment.","definition_or_measurement_approach":"uMRD4 by NGS (clonoSEQ) at specified timepoints; CRR and PFS per investigator assessment."}
  • {"endpoint_text":"- • PFS per investigator assessment. • CRR per investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and PTFU1) based on NGS (clonoSEQ).","definition_or_measurement_approach":"Investigator-assessed PFS and CRR; OS; uMRD4 rates by NGS (clonoSEQ)."}
  • {"endpoint_text":"- • ORR, defined as the proportion of patients that achieve a best response of partial response (PR) or better, as determined by the BIRC and investigator assessment. • DOR, defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurred first per the BIRC and investigator assessment.","definition_or_measurement_approach":"ORR determined by BIRC and investigator (PR or better). DOR measured from first response to documented disease progression or death per BIRC/investigator."}
  • {"endpoint_text":"- • TTR, defined as the time from the date of randomization to the date response criteria were first met, per the BIRC and investigator assessment. • TTNT, defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment. (The BIRC assessments are applicable for Arms A, B, and D only.)","definition_or_measurement_approach":"TTR measured from randomization to first meeting response criteria (BIRC/investigator); TTNT measured from randomization to start of next anti-CLL/SLL therapy; BIRC assessments apply to Arms A, B and D."}
  • {"endpoint_text":"- Rate of uMRD4 in peripheral blood at C8D1, C11D1, C14D1, C20D1, PTFU1, and subsequent follow-up timepoints","definition_or_measurement_approach":"uMRD4 measured in peripheral blood at listed timepoints by NGS (clonoSEQ)."}
  • {"endpoint_text":"- Global health status/QoL and physical functioning as measured by EORTC-QLQ-C30 and Symptom burden due to disease or treatment (symptom burden) and physical condition/fatigue (fatigue) as measured by EORTC QLQ-CLL17.","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC QLQ-C30 and EORTC QLQ-CLL17 instruments; symptom burden and fatigue scales as specified."}
  • {"endpoint_text":"- Safety (adverse events, serious adverse events, changes from baseline in clinical laboratory tests, physical examinations, and vital signs).","definition_or_measurement_approach":"Safety assessed by reporting of AEs/SAEs and changes from baseline in labs, physical exams and vital signs."}

Recruitment

Digital Remote Recruitment
True, documented use of email communication and reloadable mailers (Scout Email Communication, ScoutPass mailer), and study brochures for remote/digital outreach.
Planned Sample Size
344
Recruitment Window Months
72
Consent Approach
Informed consent provided by participants (study includes only adults ≥ 18 years). Subject information sheets and informed consent forms (L1 SIS and ICF) are available in multiple languages and versions (including country-specific versions and optional consents for sample storage and for pregnant partner information). Documented language versions include English, French, German, Dutch, Italian, Spanish, Polish, Czech, Swedish, Danish (multiple country-specific ICFs present). Optional ICFs (e.g., storage/future research) and specific partner/pregnancy information sheets are provided.

Methods

  • Site-based recruitment through participating hospitals/hematology clinics listed per country (local principal investigators and hospital sites).
  • Third-party recruitment/vendor materials and outreach (Scout Clinical): documented items include Scout Email Communication, Scout Reloadable ScoutPass Mailer, Scout Study Brochure and related patient-facing brochures/materials.
  • Country-specific recruitment arrangements documented (K1 recruitment arrangements documents available for multiple Member States).

Geography

Total Number Of Sites
70
Total Number Of Participants
285

Austria

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Internal Medicine V, Division of Hematology and Oncology
Principal Investigator Name
Jan-Paul Bohn
Principal Investigator Email
jan-paul.bohn@i-med.ac.at
Contact Person Name
Jan-Paul Bohn
Contact Person Email
jan-paul.bohn@i-med.ac.at
Site Name
Medical University Of Vienna
Department Name
Department Internal Medicine I, Division of Hematology and Hemostaseology
Principal Investigator Name
Alexander Gaiger
Principal Investigator Email
alexander.gaiger@meduniwien.ac.at
Contact Person Name
Alexander Gaiger
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
3rd Medical Department, Division of Hematology and Oncology
Principal Investigator Name
Victor Rathkolb
Principal Investigator Email
victor.rathkolb@oegk.at
Contact Person Name
Victor Rathkolb
Contact Person Email
victor.rathkolb@oegk.at

Belgium

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
70
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Principal Investigator Name
Sarah Bailly
Principal Investigator Email
sarah.bailly@saintluc.uclouvain.be
Contact Person Name
Sarah Bailly
Site Name
UZ Leuven
Department Name
Hematology
Principal Investigator Name
Ann Janssens
Principal Investigator Email
ann.janssens@uzleuven.be
Contact Person Name
Ann Janssens
Contact Person Email
ann.janssens@uzleuven.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Hematology
Principal Investigator Name
Matthias Vanderkerken
Principal Investigator Email
matthias.vanderkerken@uza.be
Contact Person Name
Matthias Vanderkerken
Contact Person Email
matthias.vanderkerken@uza.be

Denmark

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
4
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Aalborg University Hospital
Department Name
Hematology
Principal Investigator Name
Thor Høyer
Principal Investigator Email
thhc@rn.dk
Contact Person Name
Thor Høyer
Contact Person Email
thhc@rn.dk
Site Name
Rigshospitalet
Department Name
Hematology
Principal Investigator Name
Caspar Da Cunha-Bang
Principal Investigator Email
caspar.da.cunha-bang@regionh.dk
Contact Person Name
Caspar Da Cunha-Bang
Site Name
Odense University Hospital
Department Name
Hematology
Principal Investigator Name
Annika Rewes
Principal Investigator Email
annika.rewes@rsyd.dk
Contact Person Name
Annika Rewes
Contact Person Email
annika.rewes@rsyd.dk
Site Name
Region Sjaelland
Department Name
hematology
Principal Investigator Name
Christian Bjørn Poulsen
Principal Investigator Email
cbpo@regionsjaelland.dk
Contact Person Name
Christian Bjørn Poulsen
Contact Person Email
cbpo@regionsjaelland.dk

France

Earliest CTIS Part Ii Submission Date
18-08-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
43
Number Of Sites
10
Number Of Participants
39

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Principal Investigator Name
Loïc Ysebaert
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Loïc Ysebaert
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Hematology
Principal Investigator Name
Luc-Matthieu Fornecker
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Luc-Matthieu Fornecker
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Principal Investigator Name
Emmanuelle Ferrant
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Emmanuelle Ferrant
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Centre Henri Becquerel
Department Name
Hemotology
Principal Investigator Name
Stéphane Lepretre
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Stéphane Lepretre
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology
Principal Investigator Name
Sophie De Guibert
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Sophie De Guibert
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Pierre Feugier
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Pierre Feugier
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
Principal Investigator Name
Anne Lok
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Anne Lok
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Principal Investigator Name
Damien Roos-Weil
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Damien Roos-Weil
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology
Principal Investigator Name
Romain Guieze
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Romain Guieze
Contact Person Email
xxxxxxxx@xxxxxx
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hematology
Principal Investigator Name
Anne Quinquenel
Principal Investigator Email
xxxxxxxx@xxxxxx
Contact Person Name
Anne Quinquenel
Contact Person Email
xxxxxxxx@xxxxxx

Germany

Earliest CTIS Part Ii Submission Date
21-07-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
114
Number Of Sites
11
Number Of Participants
45

Sites

Site Name
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Department Name
Onkologisches Zentrum
Principal Investigator Name
Holger Hebart
Principal Investigator Email
holger.hebart@kliniken-ostalb.de
Contact Person Name
Holger Hebart
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Principal Investigator Name
Clemens Wendtner
Principal Investigator Email
clemens.wendtner@med.uni-muenchen.de
Contact Person Name
Clemens Wendtner
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Innere Medizin III
Principal Investigator Name
Christof Schneider
Principal Investigator Email
christof.schneider@uniklin-ulm.de
Contact Person Name
Christof Schneider
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik II, Hämatologie und Onkologie
Principal Investigator Name
Matthias Ritgen
Principal Investigator Email
matthias.ritgen@uksh.de
Contact Person Name
Matthias Ritgen
Contact Person Email
matthias.ritgen@uksh.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin II
Principal Investigator Name
Stefan Wirths
Principal Investigator Email
stefan.wirths@med.uni-tuebingen.de
Contact Person Name
Stefan Wirths
Site Name
Diakonie Klinikum Dietrich Bonhoeffer GmbH
Department Name
Hämatologie, Onkologie und Immunologie
Principal Investigator Name
Phillip Hemmati
Principal Investigator Email
HemmatiP@dbknb.de
Contact Person Name
Phillip Hemmati
Contact Person Email
HemmatiP@dbknb.de
Site Name
Onkologische Schwerpunktpraxis Kurfürstendamm
Principal Investigator Name
Ingo Schwaner
Principal Investigator Email
ingo.schwaner@onkologie-kurfuerstendamm.de
Contact Person Name
Ingo Schwaner
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Othman Al-Sawaf
Principal Investigator Email
othman.al-sawaf@uk-koeln.de
Contact Person Name
Othman Al-Sawaf
Contact Person Email
othman.al-sawaf@uk-koeln.de
Site Name
Haematologisch Onkologische Schwerpunktpraxis
Principal Investigator Name
Björn Schöttker
Principal Investigator Email
b.schoettker@onkopraxis-wuerzburg.de
Contact Person Name
Björn Schöttker
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Ulf Schnetzke
Principal Investigator Email
ulf.schnetzke@med.uni-jena.de
Contact Person Name
Ulf Schnetzke
Contact Person Email
ulf.schnetzke@med.uni-jena.de

Ireland

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
50
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
University Hospital Galway
Department Name
Haematology
Principal Investigator Name
Jillian Coll
Principal Investigator Email
xxxx.xxxx@hse.ie
Contact Person Name
Jillian Coll
Contact Person Email
xxxx.xxxx@hse.ie
Site Name
St James's Hospital
Department Name
Haematology
Principal Investigator Name
Carmel Waldron
Principal Investigator Email
research@stjames.ie
Contact Person Name
Carmel Waldron
Contact Person Email
research@stjames.ie
Site Name
University Hospital Limerick
Department Name
Haematology
Principal Investigator Name
Ruth Clifford
Principal Investigator Email
xxxx.xxxx@hse.ie
Contact Person Name
Ruth Clifford
Contact Person Email
xxxx.xxxx@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Principal Investigator Name
Anne Fortune
Principal Investigator Email
xxxx.xxxx@mater.ie
Contact Person Name
Anne Fortune
Contact Person Email
xxxx.xxxx@mater.ie

Italy

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
140
Number Of Sites
8
Number Of Participants
34

Sites

Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Ematologia, D.A.I. Oncologia ed Ematologia
Principal Investigator Name
Roberto Marasca
Principal Investigator Email
roberto.marasca@unimore.it
Contact Person Name
Roberto Marasca
Contact Person Email
roberto.marasca@unimore.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Clinical Trial Unit- CTU Ematologia
Principal Investigator Name
Anna Maria Frustaci
Principal Investigator Email
annamaria.frustaci@ospedaleniguarda.it
Contact Person Name
Anna Maria Frustaci
Site Name
University Hospital Of Ferrara
Department Name
Sezione di Ematologia, Dipartimento di Scienze Mediche
Principal Investigator Name
Gian Matteo Rigolin
Principal Investigator Email
rglgmt@unife.it
Contact Person Name
Gian Matteo Rigolin
Contact Person Email
rglgmt@unife.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Divisione di Ematologia
Principal Investigator Name
Annalisa Chiarenza
Principal Investigator Email
annalisa.chiarenza@gmail.com
Contact Person Name
Annalisa Chiarenza
Contact Person Email
annalisa.chiarenza@gmail.com
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
U.O. di Ematologia con Trapianto
Principal Investigator Name
Pellegrino Musto
Principal Investigator Email
pellegrino.musto@uniba.it
Contact Person Name
Pellegrino Musto
Contact Person Email
pellegrino.musto@uniba.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
CLL Department
Principal Investigator Name
Paolo Ghia
Principal Investigator Email
ghia.paolo@hsr.it
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
ARNAS G. Brotzu
Department Name
MEDICINE AND ONCOLOGY DEPARTMENT,
Principal Investigator Name
Roberta Murru
Principal Investigator Email
roberta.murru@aob.it
Contact Person Name
Roberta Murru
Contact Person Email
roberta.murru@aob.it
Site Name
ASL di Salerno - PO Andrea tortora
Department Name
UO Ematologia
Principal Investigator Name
Mariano Lucignano
Principal Investigator Email
mariano.lucignano@gmail.com
Contact Person Name
Mariano Lucignano
Contact Person Email
mariano.lucignano@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
60
Number Of Sites
10
Number Of Participants
34

Sites

Site Name
Hospital Universitario Infanta Leonor
Department Name
Hematology
Principal Investigator Name
Jose Angel Hernandez Rivas
Principal Investigator Email
jahernandezr@salud.madrid.org
Contact Person Name
Jose Angel Hernandez Rivas
Contact Person Email
jahernandezr@salud.madrid.org
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Cristina De Ramón Sanchez
Principal Investigator Email
cramon@saludcastillayleon.es
Contact Person Name
Cristina De Ramón Sanchez
Contact Person Email
cramon@saludcastillayleon.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Lucrecia Yañez San Segundo
Principal Investigator Email
Lucrecia.yanez@scsalud.es
Contact Person Name
Lucrecia Yañez San Segundo
Contact Person Email
Lucrecia.yanez@scsalud.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Hematology
Principal Investigator Name
Eduardo Ríos
Principal Investigator Email
eduardo.rios.sspa@juntadeandalucia.es
Contact Person Name
Eduardo Ríos
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Francesc Bosch
Principal Investigator Email
fbosch@vhio.net
Contact Person Name
Francesc Bosch
Contact Person Email
fbosch@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Pablo Mozas
Principal Investigator Email
mozas@clinic.cat
Contact Person Name
Pablo Mozas
Contact Person Email
mozas@clinic.cat
Site Name
Hospital Universitario De La Princesa
Department Name
Hematology
Principal Investigator Name
Javier Loscertales
Principal Investigator Email
XXX@XXX
Contact Person Name
Javier Loscertales
Contact Person Email
XXX@XXX
Site Name
Hospital Costa Del Sol
Department Name
Hematology
Principal Investigator Name
Angeles Medina
Principal Investigator Email
XXX@XXX
Contact Person Name
Angeles Medina
Contact Person Email
XXX@XXX
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Ana Carla De Oliveira Ramos
Principal Investigator Email
acoliveira@iconcologia.net
Contact Person Name
Ana Carla De Oliveira Ramos
Contact Person Email
acoliveira@iconcologia.net
Site Name
Hospital Universitario De Salamanca (additional site listed)
Department Name
Hematology
Principal Investigator Name
Cristina De Ramón Sanchez
Principal Investigator Email
cramon@saludcastillayleon.es
Contact Person Name
Cristina De Ramón Sanchez
Contact Person Email
cramon@saludcastillayleon.es

Sweden

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Department of Hematology
Principal Investigator Name
Per-Ola Andersson
Principal Investigator Email
per-ola.andersson@vgregion.se
Contact Person Name
Per-Ola Andersson
Contact Person Email
per-ola.andersson@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Mattias Mattsson
Principal Investigator Email
mattias.mattsson@akademiska.se
Contact Person Name
Mattias Mattsson
Contact Person Email
mattias.mattsson@akademiska.se
Site Name
Lund University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Daniel Roth
Principal Investigator Email
daniel.roth@skane.se
Contact Person Name
Daniel Roth
Contact Person Email
daniel.roth@skane.se
Site Name
Karolinska University Hospital
Department Name
Department of Hematology
Principal Investigator Name
Lotta Hansson
Principal Investigator Email
lotta.hansson@regionstockholm.se
Contact Person Name
Lotta Hansson

Netherlands

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
55
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Internal medicine
Principal Investigator Name
E. Van der Spek
Principal Investigator Email
evanderspek@rijnstate.nl
Contact Person Name
E. Van der Spek
Contact Person Email
evanderspek@rijnstate.nl
Site Name
Flevoziekenhuis Stichting
Department Name
Hematology
Principal Investigator Name
A.P. Kater
Principal Investigator Email
a.p.kater@amsterdamumc.nl
Contact Person Name
A.P. Kater
Contact Person Email
a.p.kater@amsterdamumc.nl
Site Name
Tergooiziekenhuizen
Department Name
Hematology
Principal Investigator Name
E. De Weerd
Principal Investigator Email
Edeweerddejong@tergooi.nl
Contact Person Name
E. De Weerd
Contact Person Email
Edeweerddejong@tergooi.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Principal Investigator Name
M-D Levin
Principal Investigator Email
m-d.levin@asz.nl
Contact Person Name
M-D Levin
Contact Person Email
m-d.levin@asz.nl

Poland

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
71
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Katedra i Klinika Hematologii, Transplantologii i Chorob Wewnetrznych
Principal Investigator Name
Krzysztof Jamroziak
Principal Investigator Email
kho.csk@uckwum.pl
Contact Person Name
Krzysztof Jamroziak
Contact Person Email
kho.csk@uckwum.pl
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddzial Hematologii
Principal Investigator Name
Marcin Rymko
Principal Investigator Email
XX@XX
Contact Person Name
Marcin Rymko
Contact Person Email
XX@XX
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
XX@XX
Contact Person Name
Tomasz Wrobel
Contact Person Email
XX@XX
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddzial Hematologii Ogolnej i Chorob Wewnetrznych
Principal Investigator Name
Tadeusz Robak
Principal Investigator Email
badania.kliczne@kopernik.lodz.pl
Contact Person Name
Tadeusz Robak
Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
XX@XX
Contact Person Name
Jan Zaucha
Contact Person Email
XX@XX

Czechia

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
70
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinka
Principal Investigator Name
Michael Doubek
Principal Investigator Email
xx@xx
Contact Person Name
Michael Doubek
Contact Person Email
xx@xx
Site Name
Ustav Hematologie A krevni Transfuze
Department Name
Oddělení buněčné terapie
Principal Investigator Name
Robert Pytlík
Principal Investigator Email
xx@xx
Contact Person Name
Robert Pytlík
Contact Person Email
xx@xx
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Principal Investigator Name
Martin Šimkovič
Principal Investigator Email
xx@xx
Contact Person Name
Martin Šimkovič
Contact Person Email
xx@xx
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interní klinika - klinika hematologie 1.LF a VFN
Principal Investigator Name
Martin Špaček
Principal Investigator Email
xx@xx
Contact Person Name
Martin Špaček
Contact Person Email
xx@xx

Sponsor

Primary sponsor

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

Contract research organisations

Name
Scout Clinical
Responsibilities
Patient reimbursement / recruitment-related materials (contact: clientcompliance@scoutclinical.com)
Name
Wuxi Apptec (Shanghai) Co. Ltd.
Responsibilities
Operational vendor (sponsor duty code listed; specific responsibilities not detailed)
Name
Clinchoice Enterprise Management Shanghai Limited
Responsibilities
Operational vendor (sponsor duty code listed; specific responsibilities not detailed)
Name
4G Clinical B.V.
Responsibilities
Operational/vendor support (sponsor duty code listed; specific responsibilities not detailed)
Name
Icon Clinical Research Limited
Responsibilities
Clinical trial agreements and CRO functions (contact: CTIS-Biotech@iconplc.com)
Name
Medidata Solutions Inc.
Responsibilities
Data platform/vendor services (sponsor duty code listed; specific responsibilities not detailed)
Name
Bioclinica Inc.
Responsibilities
Imaging Services
Name
Laboratory Corporation Of America Holdings
Responsibilities
Central laboratory services
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services

Third parties

  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"China","full_name":"Wuxi Apptec (Shanghai) Co. Ltd.","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duty code: 7 (specific role not detailed in provided data)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Clinchoice Enterprise Management Shanghai Limited","duties_or_roles":"Sponsor duty code: 13 (specific role not detailed in provided data)","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Synevo Sp. z o.o.","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Sponsor duty code: 14 (specific role not detailed in provided data)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"Sponsor duty code: 3 (specific role not detailed in provided data)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"ID/Calibration Samples and MRD/Tracking Samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Clinical Trial Agreements","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sponsor duty code: 4 (specific role not detailed in provided data)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi","duties_or_roles":"Provider for paper version of Questionnaires","organisation_type":"Patient organisation/association"}

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
Investigational (product in trial; prodAuthStatus indicates non-marketed investigational product in listing)
Maximum Dose
320 mg (max daily dose amount listed)
Investigational Product Name
Venclyxto (venetoclax) (10/50/100 mg film-coated tablets)
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present for venetoclax (marketing authorisation numbers provided in product listing)
Maximum Dose
400 mg (max daily dose amount listed)
Investigational Product Name
MabThera (rituximab) (100 mg and 500 mg concentrate for solution for infusion)
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Marketing authorisation present for rituximab (marketing authorisation numbers provided in product listing)
Maximum Dose
500 mg/m2 (max daily dose amount listed; dose expressed mg/m2)
Investigational Product Name
Gazyvaro (obinutuzumab) 1,000 mg concentrate for solution for infusion
Active Substance
OBINUTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Marketing authorisation present (orphan designation noted EU/3/15/1504)
Orphan Designation
Yes
Maximum Dose
1,000 mg (max daily dose amount listed)
Combination Treatment
Yes

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