Clinical trial • Phase III • Oncology

ZANUBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Phase III trial of ZANUBRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
26-04-2024
First CTIS Authorization Date
06-06-2024

Trial design

Randomised, open-label, bendamustine plus rituximab (b+r) (comparator arm; dosing/schedule not specified in provided data); venetoclax (venclyxto 50 mg/100 mg film-coated tablets) in combination with zanubrutinib in arm d (dosing/schedule not specified in provided data); rituximab (mabthera 500 mg concentrate for solution for infusion) used in combination with bendamustine as part of b+r comparator (dosing schedule not specified in provided data).-controlled Phase III trial across 58 sites in Spain, Poland, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Bendamustine plus rituximab (B+R) (comparator arm; dosing/schedule not specified in provided data); Venetoclax (Venclyxto 50 mg/100 mg film-coated tablets) in combination with zanubrutinib in Arm D (dosing/schedule not specified in provided data); Rituximab (MabThera 500 mg concentrate for solution for infusion) used in combination with bendamustine as part of B+R comparator (dosing schedule not specified in provided data).
Biomarker Stratified
True, biomarker: del17p status by central FISH (del17p-positive vs del17p-negative); pathogenic TP53 variant by local test may be used to assign del17p-positive subset eligibility
Target Sample Size
342

Eligibility

Recruits 342 Vulnerable population selected. Participants must have the ability to provide written informed consent and to understand and comply with study requirements. Subject information and informed consent forms (L1 SIS and ICF) are provided (multiple country/language versions listed in documents). No paediatric assent procedures are described in the available materials..

Pregnancy Exclusion
Pregnant or lactating women
Vulnerable Population
Vulnerable population selected. Participants must have the ability to provide written informed consent and to understand and comply with study requirements. Subject information and informed consent forms (L1 SIS and ICF) are provided (multiple country/language versions listed in documents). No paediatric assent procedures are described in the available materials.

Inclusion criteria

  • {"criterion_text":"- Patients must be unsuitable for treatment with FCR defined as: ≥ 65 years of age at the time of informed consent, OR 18 - 64 years of age and have one or more of the following factors: a.\tCumulative Illness Rating Scale (CIRS) score > 6. A CIRS is not required, it may be used to meet this inclusion requirement. b.\tCreatinine clearance < 70 mL/min c.\tHistory of previous serious infection or multiple infections in the past 2 years NOTE: For Arm D only: -Patients without del17p: must meet one of the above criteria for unsuitability for FCR. -Patients with del17p/TP53 variant: central laboratory confirmation of del17p-positive CLL/SLL will fulfill the requirement for unsuitability for FCR. For patients with a central FISH test result other than del17ppositive CLL/SLL, a local laboratory test result documenting pathogenicTP53 variant may meet this requirement (refer to Appendix 18 of PA5)."}
  • {"criterion_text":"- Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib or 3 months after the last dose of bendamustine whichever is longer"}
  • {"criterion_text":"- Ability to provide written informed consent and can understand and comply with the requirements of the study"}
  • {"criterion_text":"- Must have FISH results from the study-specified central laboratory confirming the presence or absence of del17p.a. For Arm D only: Patients must have a central laboratory FISH test for del17p performed. A patient with a result other than \"with del17p\" may be eligible for enrollment into the del17p-positive subset only if the patient has a pathogenic TP53 variant previously documented per local laboratory test meeting the criteria specified in Appendix 18."}
  • {"criterion_text":"- Confirmed diagnosis of CD20-positive CLL or SLL that meets the CLL criteria (Hallek et al, 2008)"}
  • {"criterion_text":"- Measurable disease by CT/MRI. Measurable disease is defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters"}
  • {"criterion_text":"- CLL/SLL requiring treatment"}
  • {"criterion_text":"- ECOG performance status of 0, 1, or 2"}
  • {"criterion_text":"- Life expectancy ≥ 6 months"}
  • {"criterion_text":"- Adequate bone marrow function"}
  • {"criterion_text":"- Patient must have adequate organ function"}
  • {"criterion_text":"- Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib, ≥ 30 days after the last dose of venetoclax,3 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer"}

Exclusion criteria

  • {"criterion_text":"- Previous systemic treatment for CLL/SLL"}
  • {"criterion_text":"- Requires ongoing need for corticosteroid treatment. NOTE: Systemic corticosteroids must be fully tapered off/stopped at least 5 days before day of first study drug"}
  • {"criterion_text":"- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation"}
  • {"criterion_text":"- Clinically significant cardiovascular disease"}
  • {"criterion_text":"- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer"}
  • {"criterion_text":"- History of severe bleeding disorder"}
  • {"criterion_text":"- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug"}
  • {"criterion_text":"- Severe or debilitating pulmonary disease"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Active fungal, bacterial and/or viral infection requiring systemic therapy"}
  • {"criterion_text":"- Concurrent participation in another therapeutic clinical study"}
  • {"criterion_text":"- Known infection with HIV, or serologic status reflecting active hepatitis B or C infection"}
  • {"criterion_text":"- Major surgery within 4 weeks of the first dose of study drug"}
  • {"criterion_text":"- Pregnant or lactating women"}
  • {"criterion_text":"- Ongoing alcohol or drug addiction"}
  • {"criterion_text":"- Hypersensitivity to zanubrutinib, bendamustine, rituximab or venetoclax (as applicable) or any of the other ingredients of the applicable study drugs"}
  • {"criterion_text":"- Requires ongoing treatment with a strong CYP3A inhibitor or inducer"}
  • {"criterion_text":"- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura)"}
  • {"criterion_text":"- Arm D only: requires ongoing treatment with warfarin or warfarin derivatives"}
  • {"criterion_text":"- Known central nervous system involvement by leukemia or lymphoma"}
  • {"criterion_text":"- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs"}
  • {"criterion_text":"- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura)"}
  • {"criterion_text":"- Active fungal, bacterial and/or viral infection requiring systemic therapy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is PFS in Cohort 1 (patients without del17p) determined by central review using the iwCLL guidelines with modification for treatment-related lymphocytosis in patients with CLL and the Revised Criteria for Response for Malignant Lymphoma in patients with SLL, and defined as the time from randomization to disease progression or death","definition_or_measurement_approach":"Determined by independent central review using iwCLL guidelines with modification for treatment-related lymphocytosis (for CLL) and Revised Criteria for Response for Malignant Lymphoma (for SLL); defined as time from randomization to disease progression or death."}

Secondary endpoints

  • {"endpoint_text":"- ORR in Cohort 1 defined as the proportion of patients who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by independent central review and by investigator assessment","definition_or_measurement_approach":"Proportion achieving CR, CR with incomplete marrow recovery, PR, or PR with lymphocytosis by independent central review and investigator assessment."}
  • {"endpoint_text":"- OS in Cohort 1 defined as the time from randomization to the date of death due to any reason","definition_or_measurement_approach":"Time from randomization to death from any cause."}
  • {"endpoint_text":"- Duration of response in Cohort 1 determined by central review and by investigator assessment using the iwCLL criteria with modification for treatment-related lymphocytosis (in patients with CLL) and the Lugano Classification for NHL (in patients with SLL), and defined as the time from the date that criteria for response are first met to disease progression or death","definition_or_measurement_approach":"Time from first documented response to disease progression or death; assessed by central review and investigator using iwCLL (with modification) and Lugano classification."}
  • {"endpoint_text":"- PFS in Cohort 1 determined by investigator assessment","definition_or_measurement_approach":"Progression-free survival assessed by investigator."}
  • {"endpoint_text":"- PROs in Cohort 1 measured by the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ-5D-5L) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Patient-reported outcomes using EQ-5D-5L and EORTC QLQ-C30 instruments."}
  • {"endpoint_text":"- PFS in pooled Cohort 1/1a patients from Chinese sites determined by independent central review and by investigator assessment","definition_or_measurement_approach":"PFS for pooled Cohort 1/1a Chinese-site patients by central review and investigator assessment."}
  • {"endpoint_text":"- ORR in pooled Cohort 1/1a patients from Chinese sites determined by independent central review and by investigator assessment","definition_or_measurement_approach":"ORR in pooled Cohort 1/1a Chinese-site patients by central review and investigator assessment."}
  • {"endpoint_text":"- Duration of response in pooled Cohort 1/1a patients from Chinese sites determined by independent central review and by investigator assessment","definition_or_measurement_approach":"Duration of response in pooled Cohort 1/1a Chinese-site patients by central review and investigator assessment."}
  • {"endpoint_text":"- ORR in Cohort 2 (patients with del17p), Arm C, determined by independent central review and investigator review","definition_or_measurement_approach":"ORR in Cohort 2 by central and investigator review."}
  • {"endpoint_text":"- PFS in Cohort 2 (Arm C), determined by independent central review and investigator review","definition_or_measurement_approach":"PFS in Cohort 2 by central and investigator review."}
  • {"endpoint_text":"- Duration of response in Cohort 2 (Arm C), determined by independent central review and investigator review","definition_or_measurement_approach":"Duration of response in Cohort 2 by central and investigator review."}
  • {"endpoint_text":"- ORR in Cohort 3, Arm D, determined by investigator review","definition_or_measurement_approach":"ORR in Cohort 3 assessed by investigator."}
  • {"endpoint_text":"- PFS in Cohort 3 (Arm D), determined by investigator review","definition_or_measurement_approach":"PFS in Cohort 3 assessed by investigator."}
  • {"endpoint_text":"- Duration of response in Cohort 3 (Arm D), determined by investigator review","definition_or_measurement_approach":"Duration of response in Cohort 3 assessed by investigator."}
  • {"endpoint_text":"- Cohort 3 (Arm D) only: undetectable MRD4 rate","definition_or_measurement_approach":"Rate of undetectable minimal residual disease at 10^-4 sensitivity in Cohort 3 (Arm D)."}
  • {"endpoint_text":"- Safety parameters, including AEs, SAEs, clinical laboratory tests, physical examination, and vital signs","definition_or_measurement_approach":"Standard safety assessments: adverse events, serious adverse events, labs, physical exam, vital signs."}
  • {"endpoint_text":"- Pharmacokinetic parameters of zanubrutinib such as apparent clearance of the drug from plasma (CL/F) and AUC from time 0 to 12 hours postdose (AUC0-12) for Arms A, C, and D","definition_or_measurement_approach":"PK parameters including CL/F and AUC0-12 measured in specified arms (A, C, D)."}

Recruitment

Planned Sample Size
342
Recruitment Window Months
129
Consent Approach
Written informed consent required from participants ("Ability to provide written informed consent"). Subject information and informed consent forms (L1 SIS and ICF) are available and provided in multiple country/language versions (documents list includes Dutch, French, Spanish, Polish, Swedish, Czech, Italian and other national versions; also documents for pregnant partner, future research and PK substudy). No pediatric assent procedures are described in the available materials.

Geography

Total Number Of Sites
58
Total Number Of Participants
437

Spain

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
624
Number Of Sites
9
Number Of Participants
35

Sites

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
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Jose Juan Damaj (listed as contact: Jose Juan Rifon Roca)
Contact Person Email
jrifon@unav.es
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Jose Juan Rifon Roca
Contact Person Email
jrifon@unav.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Contact Person Name
Jose Antonio Garcia Vela
Site Name
Hospital Germans Trias I Pujol
Department Name
Hematology
Contact Person Name
Gladys Ibarra Fernandez
Contact Person Email
Gibarra2601@hotmail.com
Site Name
Consorci Mar Parc De Salut De Barcelona
Department Name
Hematology
Contact Person Name
Eva Gimeno Vazquez
Contact Person Email
94015@parcdesalutmar.cat
Site Name
Hospital Quironsalud Zaragoza
Department Name
Hematology
Contact Person Name
Maria Pilar Giraldo Castellano
Contact Person Email
giraldocastellano@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Contact Person Name
Rafael Andreu Lapiedra
Contact Person Email
andreu_raflap@gva.es
Site Name
Hospital Universitario De La Princesa
Department Name
Hematology
Contact Person Name
Javier Loscertales Pueyo
Contact Person Email
jloscertales@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
626
Number Of Sites
8
Number Of Participants
125

Sites

Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Hematology
Contact Person Name
Jacek Krzanowski
Contact Person Email
jacek.krzanowski@gmail.com
Site Name
Pratia S.A.
Department Name
Hematology
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Hematology
Contact Person Name
Pawel Kicinski
Contact Person Email
pkicinski@cozl.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Department Name
Hematology
Contact Person Name
Izabela Kozłowska-Karaca
Contact Person Email
XX@XX
Site Name
Wojewodzki Szpital Specjalistyczny W Legnicy
Department Name
Hematology
Contact Person Name
Jadwiga Hołojda
Contact Person Email
j.holojda@gmail.com
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Hematology
Contact Person Name
Tadeusz Robak
Contact Person Email
robaktad@csk.umed.lodz.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Hematology
Contact Person Name
Hanna Ciepłuch
Contact Person Email
ciepluch@gumed.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Hematology
Contact Person Name
Sebastian Giebel
Contact Person Email
sebastian.giebel@io.gliwice.pl

Belgium

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
620
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Haematology
Contact Person Name
Marie Lejeune
Contact Person Email
marie.lejeune@chuliege.be
Site Name
UZ Brussel
Department Name
Haematology
Contact Person Name
Henri Schots
Contact Person Email
rik.schots@uzbrussel.be
Site Name
Clinique Saint-Pierre
Department Name
Haematology
Contact Person Name
Thierry Connerotte
Contact Person Email
thierry.connerotte@cspo.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Haematology
Contact Person Name
Fritz Offner
Contact Person Email
fritz.offner@uzgent.be

Austria

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
627
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Internal I - Internal Oncology, Hematology and Gastroenterology
Contact Person Name
Holger Rumpold
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Internal Medicine V, Hematology and Oncology
Contact Person Name
Ella Willenbacher
Contact Person Email
ella.willenbacher@i-med.ac.at
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Internal Medicine III
Contact Person Name
Alexander Egle
Contact Person Email
a.eagle@salk.at

Sweden

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
620
Number Of Sites
7
Number Of Participants
36

Sites

Site Name
Region Oerebro Laen
Department Name
Hematologsektionen, Hematologmottagningen
Contact Person Name
Bertil Uggla
Site Name
Uppsala University Hospital
Department Name
Department of Hematology
Contact Person Name
Mattias Mattsson
Contact Person Email
mattias.mattsson@akademiska.se
Site Name
Karolinska University Hospital
Department Name
Hematology department
Contact Person Name
Anders Österborg
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematologiavdelning
Contact Person Name
Oscar Lindblad
Contact Person Email
oscar.lindbald@med.lu.se
Site Name
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Department Name
Hematology day care
Contact Person Name
Per-ola Andersson
Contact Person Email
Per-ola.andersson@vgregion.se
Site Name
Region Norrbotten
Department Name
Sunderby sjukhus, Medicinkliniken
Contact Person Name
Birgitta Lauri
Contact Person Email
forskning@norrbotten.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Department of Hematology and Coagulation
Contact Person Name
Catharina Lewerin
Contact Person Email
catharina.lewerin@vgregion.se

Czechia

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
620
Number Of Sites
4
Number Of Participants
50

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Internal Hematology and Oncology Clinic
Contact Person Name
Anna Panovská
Contact Person Email
Panovska.Anna@fnbrno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
The 4th Department of Internal Medicine - Hematology
Contact Person Name
Martin Šimkovič
Contact Person Email
simkovicm@lfhk.cuni.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. Internal Clinic - Hematology Clinic
Contact Person Name
Marek Trnĕný
Contact Person Email
trneny@cesnet.cz
Site Name
University Hospital Olomouc
Department Name
Hemato-Oncology Clinic
Contact Person Name
Tomáš Papajík
Contact Person Email
tomas.papajik@fnol.cz

Italy

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
621
Number Of Sites
8
Number Of Participants
75

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncology and Hematology
Contact Person Name
Anna Maria Frustaci
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Hematology
Contact Person Name
Luca Laurenti
Contact Person Email
luca.laurenti@unicatt.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Universita' Degli Studi Di Modena E Reggio Emilia
Department Name
Hematology
Contact Person Name
Roberto Marasca
Contact Person Email
roberto.marasca@unimore.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Hematology
Contact Person Name
Candida Vitale
Contact Person Email
candida.vitale@unito.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Hematology
Contact Person Name
Michele Merli
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology and Hematology
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncohaematology
Contact Person Name
Arcangelo Liso
Contact Person Email
arcangelo.liso@unipg.it

France

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
624
Number Of Sites
15
Number Of Participants
70

Sites

Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Haematology
Contact Person Name
Gandhi Laurent Damaj
Contact Person Email
damaj.gl@chu-caen.fr
Site Name
Hospices Civils De Lyon
Department Name
Haematology
Contact Person Name
Emmanuelle Ferrant
Site Name
Institut Bergonie
Department Name
Haematology
Contact Person Name
Fontanet Bijou
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Centre Henri Becquerel
Department Name
Haematology
Contact Person Name
Stephane Lepretre
Site Name
Hopital Universitaire Pitie Salpetriere
Department Name
Haematology
Contact Person Name
Damien Roos-Weil
Contact Person Email
damien.roosweil@aphp.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Haematology
Contact Person Name
Kamel Laribi
Contact Person Email
klariby@ch-lemans.fr
Site Name
Institut Paoli Calmettes
Department Name
Haematology
Contact Person Name
Anne Calleja
Contact Person Email
callejaa@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Gastroenterology
Contact Person Name
Anne Quinquenel
Contact Person Email
a.quinquenel@chu-reims.fr
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Haematology
Contact Person Name
Mariem Romdhani
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Haematology
Contact Person Name
Liliane Remenieras
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Haematology
Contact Person Name
François-Xavier Gros
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Haematology
Contact Person Name
Caroline Dartigeas
Contact Person Email
c.dartigeas@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Haematology
Contact Person Name
Sophie De Guibert
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Haematology
Contact Person Name
Chloe Antier
Contact Person Email
chloe.antier@chu-nantes.fr
Site Name
CHRU De Nancy
Department Name
Haematology
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
IVRS – treatment randomisation (as listed in third-party sponsor duties)
Name
PPD (UK) Limited
Responsibilities
Pharmacovigilance

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"IVRS – treatment randomisation (plus sponsor duties indicated by codes in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Inc.","duties_or_roles":"del(17p), Cytogenetics, IGHV mutation analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"NeoGenomics Europe S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Xenobiotic Laboratories Inc.","duties_or_roles":"PK, bioanalysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Zanubrutinib
Active Substance
ZANUBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Not authorised (prodAuthStatus:1)
Maximum Dose
320 mg (maxDailyDoseAmount)
Investigational Product Name
Venclyxto 50 mg film-coated tablets
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised/Marketing authorisation (prodAuthStatus:2)
Maximum Dose
400 mg (maxDailyDoseAmount)
Investigational Product Name
Venclyxto 100 mg film-coated tablets
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised/Marketing authorisation (prodAuthStatus:2)
Maximum Dose
400 mg (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
Authorisation Status
Authorised/Marketing authorisation (prodAuthStatus:2)
Maximum Dose
500 mg/m2 (maxDailyDoseAmount)
Combination Treatment
Yes

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