Clinical trial • Phase III • Oncology

acalabrutinib for Mantle cell lymphoma

Phase III trial of acalabrutinib 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
25-04-2024
First CTIS Authorization Date
31-05-2024

Trial design

Randomised, arm 1: acalabrutinib (calquence 100 mg hard capsules, active substance acalabrutinib; oral) in combination with bendamustine (bendamustine hydrochloride; intravenous, dose reported in mg/m2 in product data) and rituximab (rituximab; intravenous). arm 2: placebo (hard capsule) plus bendamustine (intravenous) and rituximab (intravenous). specific numeric dosing and schedules are not provided in the available part i/part ii metadata.-controlled Phase III trial in Italy, Belgium, Czechia and others.

Randomised
Yes
Comparator
Arm 1: acalabrutinib (Calquence 100 mg hard capsules, active substance acalabrutinib; oral) in combination with bendamustine (bendamustine hydrochloride; intravenous, dose reported in mg/m2 in product data) and rituximab (rituximab; intravenous). Arm 2: placebo (hard capsule) plus bendamustine (intravenous) and rituximab (intravenous). Specific numeric dosing and schedules are not provided in the available Part I/Part II metadata.
Target Sample Size
438

Eligibility

Recruits 438 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants must be able to understand the purpose and risks of the study and provide signed and dated informed consent (inclusion criterion: "Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)."). No assent or minor/guardian consent provisions are specified in the available Part I/Part II data..

Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants must be able to understand the purpose and risks of the study and provide signed and dated informed consent (inclusion criterion: "Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)."). No assent or minor/guardian consent provisions are specified in the available Part I/Part II data.

Inclusion criteria

  • {"criterion_text":"- Men and women, ≥65 years of age."}
  • {"criterion_text":"- Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5)."}
  • {"criterion_text":"- MCL requiring treatment and for which no prior systemic anticancer therapies have been received."}
  • {"criterion_text":"- Presence of radiologically measurable lymphadenopathy and/or extranodal lymphoid malignancy."}
  • {"criterion_text":"- ECOG performance status of ≤2."}
  • {"criterion_text":"- Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest."}
  • {"criterion_text":"- Men must agree to refrain from sperm donation during the study and for 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest."}
  • {"criterion_text":"- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty."}
  • {"criterion_text":"- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)."}

Exclusion criteria

  • {"criterion_text":"- History of prior malignancy except for the following: a.\tMalignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician. Note: Provided they meet other eligibility criteria, subjects who are receiving hormonal therapy alone are allowed to enroll on study. b.\tAdequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer. c.\tAdequately treated carcinoma in situ without current evidence of disease."}
  • {"criterion_text":"- Uncontrolled AIHA or ITP."}
  • {"criterion_text":"- Major surgical procedure within 28 days before first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug."}
  • {"criterion_text":"- Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study."}
  • {"criterion_text":"- ANC < 1.0 x 109/L or platelet count < 75 x 109/L; for subjects with disease involvement in the bone marrow, ANC < 0.75 x 109/L or platelet count < 50 x 109/L. Subjects will only be considered eligible if peripheral blood counts can be maintained independent of growth factors or transfusions during the screening period."}
  • {"criterion_text":"- Total bilirubin > 1.5 x ULN; or AST or ALT > 2.5 x ULN."}
  • {"criterion_text":"- Estimated creatinine clearance of < 50 mL/min, calculated using the formula of Cockcroft and Gault [(140-age)•mass (kg)/(72•creatinine mg/dL)•multiply by 0.85 if female]."}
  • {"criterion_text":"- Serologic status reflecting active hepatitis B or C infection."}
  • {"criterion_text":"- Received a live virus vaccination within 28 days of first dose of study drug."}
  • {"criterion_text":"- History of stroke or intracranial hemorrhage within 6 months of first dose of study drug."}
  • {"criterion_text":"- History of bleeding diathesis (e.g., hemophilia or von Willebrand disease)."}
  • {"criterion_text":"- Prothrombin time/INR or aPTT (in the absence of a Lupus anticoagulant) > 2.0 x ULN. Exception: Subjects receiving warfarin are excluded; however, those receiving other anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this study after discussion with the medical monitor."}
  • {"criterion_text":"- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug."}
  • {"criterion_text":"- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug."}
  • {"criterion_text":"- Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer."}
  • {"criterion_text":"- Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study."}
  • {"criterion_text":"- Concurrent participation in another therapeutic clinical trial."}
  • {"criterion_text":"- Active cytomegalovirus (CMV) infection (active viremia as evidenced by positive polymerase chain reaction [PCR] result for CMV DNA)."}
  • {"criterion_text":"- History of confirmed progressive multifocal leukoencephalopathy (PML)."}
  • {"criterion_text":"- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass."}
  • {"criterion_text":"- Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug."}
  • {"criterion_text":"- Known history of infection with HIV."}
  • {"criterion_text":"- Ongoing immunosuppressive therapy, including systemic (eg, IV or oral) corticosteroids within 2 weeks before the first dose of study drug. Note: Subjects may use topical or inhaled corticosteroids or low dose steroids (≤ 20 mg prednisone equivalent/day for ≤ 2 weeks) as a therapy for comorbid conditions. During study participation, subjects may also receive systemic (eg, IV or oral) corticosteroids as needed for treatment emergent comorbid conditions."}
  • {"criterion_text":"- Known history of anaphylaxis or hypersensitivity to bendamustine, rituximab, or any of their components."}
  • {"criterion_text":"- Subjects for whom the goal of therapy is tumor debulking before stem cell transplant."}
  • {"criterion_text":"- Any history of CNS lymphoma or leptomeningeal disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).","definition_or_measurement_approach":"Progression-free survival (PFS) assessed by an Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (Cheson 2014); primary analysis compares PFS between Arm 1 (acalabrutinib + BR) and Arm 2 (placebo + BR)."}

Secondary endpoints

  • {"endpoint_text":"- Investigator-assessed PFS per the Lugano Classification for NHL","definition_or_measurement_approach":"Investigator-assessed progression-free survival (PFS) per the Lugano Classification for NHL."}
  • {"endpoint_text":"- Investigator-assessed ORR per the Lugano Classification for NHL","definition_or_measurement_approach":"Investigator-assessed overall response rate (ORR) per the Lugano Classification for NHL."}
  • {"endpoint_text":"- IRC-assessed ORR (CR+PR) per the Lugano Classification for NHL","definition_or_measurement_approach":"IRC-assessed overall response rate (ORR; CR + PR) per the Lugano Classification for NHL."}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS); definition/timepoint not further specified in Part I data."}
  • {"endpoint_text":"- IRC-assessed duration of response (DOR) per the Lugano Classification for NHL","definition_or_measurement_approach":"Duration of response (DOR) assessed by IRC per the Lugano Classification for NHL."}
  • {"endpoint_text":"- IRC-assessed time to response (TTR) per the Lugano Classification for NHL","definition_or_measurement_approach":"Time to response (TTR) assessed by IRC per the Lugano Classification for NHL."}
  • {"endpoint_text":"- Pharmacokinetic (PK) characteristics of acalabrutinib and its active metabolite (ACP-5862), alone and when given in combination with bendamustine","definition_or_measurement_approach":"Pharmacokinetic (PK) profiling of acalabrutinib and ACP-5862 (parameters not specified in Part I data); assessed alone and in combination with bendamustine."}

Recruitment

Planned Sample Size
438
Recruitment Window Months
122
Consent Approach
Participants must be able to understand the study purpose and risks and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Country-/site-specific subject information sheets and ICFs are submitted (examples of available ICF documents in the dossier: Italian, Greek, French, Polish, Spanish, Hungarian, Czech and country-specific/redacted BE versions), indicating use of local-language ICFs; no minor/assent procedures are specified in the available Part I/Part II metadata.

Geography

Total Number Of Sites
53
Total Number Of Participants
198

Italy

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
05-06-2024
Processing Time Days
15
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Dipartimento Oncologia, SC Ematologia
Contact Person Name
Luca Arcaini
Contact Person Email
luca.arcaini@unipv.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UO Ematologia Centro Ricerche Cliniche
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
P.O Cervello- UOC Oncoematologia
Contact Person Name
Caterina Patti
Contact Person Email
k.patti@villasofia.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
SC Ematologia e Centro Trapianti Midollo Osseo
Contact Person Name
Caterina Plenteda
Contact Person Email
cplenteda@ao.pr.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Azienda Ospedaliera Ospedale Niguarda Ca Granda SC Ematologia
Contact Person Name
Vittorio Ruggero Zilioli
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C Ematologia- Presidio Molinette
Contact Person Name
Carola Boccomini
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC Ematologia-Arcispedale S. Maria Nuova Reggio Emilia
Contact Person Name
Stefano Luminari
Contact Person Email
Stefano.Luminari@ausl.re.it

Belgium

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
13
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
UZ Leuven
Department Name
Haematology
Contact Person Name
Vibeke Vergote
Contact Person Email
Vibeke.vergote@uzleuven.be
Site Name
Jan Yperman Ziekenhuis
Department Name
Haematology
Contact Person Name
Hilde Demuynck
Contact Person Email
Hilde.demuynck@yperman.net
Site Name
Vitaz
Department Name
Haematology
Contact Person Name
Vanessa Van Hende
Contact Person Email
Vanessa.vanhende@aznikolaas.be

Czechia

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
04-06-2024
Processing Time Days
14
Number Of Sites
5
Number Of Participants
53

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Hemato-oncology Clinic
Contact Person Name
Roman Hajek
Contact Person Email
roman.hajek@fno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hemato-oncology Centrum
Contact Person Name
Jan Novak
Contact Person Email
jan.novak@lf3.cuni.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Internal medicine, Hematology and Oncology
Contact Person Name
David Salek
Contact Person Email
salek.david@fnbrno.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Hemato-oncology department
Contact Person Name
Pavel Jindra
Contact Person Email
jindra@fnplzen.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. Internal and Hematology Clinic
Contact Person Name
David Belada
Contact Person Email
david.belada@fnhk.cz

Germany

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
04-06-2024
Processing Time Days
14
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik
Contact Person Name
Georg Hess
Contact Person Email
georg.hess@unimedizin-mainz.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fur Innere Medizin III
Contact Person Name
Stephan Stilgenbauer
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik III
Contact Person Name
Martin Dreyling
Site Name
MVZ W8 Onkologische Praxis
Department Name
private practice
Contact Person Name
Dirk Tummes
Contact Person Email
tummes@onkologie-aachen.de

Spain

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
10
Number Of Sites
10
Number Of Participants
27

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Haematology
Contact Person Name
Ana Marin Niebla
Contact Person Email
ana.marinniebla@vallhebron.cat
Site Name
Institut Catala D'oncologia
Department Name
Haematology
Contact Person Name
Eva Maria Gonzalez Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Haematology
Contact Person Name
Guillermo Rodriguez Garcia
Contact Person Email
grgarcia@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Haematology
Contact Person Name
Sergio Ramos Cillan
Contact Person Email
Sergio.ramos@startmadrid.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Haematology
Contact Person Name
Mariana Bastos Oreiro
Site Name
Hospital Universitario La Paz
Department Name
Haematology
Contact Person Name
Victor Jimenez Yuste
Contact Person Email
Vjyuste.ensayos@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Haematology
Contact Person Name
Juan Manuel Sancho
Contact Person Email
jsancho@iconcologia.net
Site Name
Hospital Del Mar
Department Name
Haematology
Contact Person Name
Antonio Salar Silvestre
Contact Person Email
asalar@hospitaldelmar.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Haematology
Contact Person Name
Jose Antonio Garcia Vela
Site Name
Hospital Germans Trias I Pujol (duplicate entry avoided)

Hungary

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
04-06-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
University Of Debrecen
Department Name
Department of Internal Medicine, Hematology
Contact Person Name
Arpad Illes
Contact Person Email
illesarpadDr@gmail.com
Site Name
University Of Szeged
Department Name
2nd Department of Internal Medicine, Hematology
Contact Person Name
Zita Borbenyi
Contact Person Email
borbenyizita@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
2nd Department of Internal Medicine, Hematology
Contact Person Name
Zsolt Lazar
Contact Person Email
lazarzsoltika@freemail.hu

Greece

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
34
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
General University Hospital Of Patras
Department Name
Hematology Division, Internal Medicine Department
Contact Person Name
Alexandros Spyridonidis
Contact Person Email
spyridonidis@upatras.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department -BMT Unit, Gene and Cell Therapy Centre
Contact Person Name
Niki Stavroyianni
Contact Person Email
niki.stavroyianni@gmail.com
Site Name
Theageneio Cancer Hospital
Department Name
Haematology Department
Contact Person Name
Eirini Katodritou
Contact Person Email
eirinikatodritou@gmail.com
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Contact Person Name
Meletios-Athanassios Dimopoulos
Contact Person Email
mdimpo@med.uoa.gr
Site Name
Laiko General Hospital Of Athens
Department Name
Haematology Clinic and Βone Μarrow Τransplantation Unit, NKUA
Contact Person Name
Panayiotis Panayiotidis
Contact Person Email
ppanayt@med.uoa.gr
Site Name
University General Hospital Of Ioannina
Department Name
Department of Hematology
Contact Person Name
Eleni Kapsali
Contact Person Email
elkapsali@gmail.com

France

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
10
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Institut Bergonie
Department Name
Hematologie
Contact Person Name
Fontanet BIJOU
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Service d Onco-Hematologie
Contact Person Name
Kamel LARIBI
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service d Hematologie Clinique
Contact Person Name
Sophie DE GUILBERT
Contact Person Email
sophie.deguibert@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service Oncologie Hematologique et Therapie Cellulaire - CIC Inserm 1402
Contact Person Name
Vincent DELWAIL
Contact Person Email
v.delwail@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
GH Sud Haut-Leveque Centre Francois Magendie - Service d Hematologie et Therapie Cellulaire
Contact Person Name
Kamal Krimo BOUABDALLAH

Poland

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Department Name
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
Contact Person Name
Piotr Malecki
Contact Person Email
badania_kliniczne@zsm.com.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddzia Hematologiczny
Contact Person Name
Pawel Kicinski
Contact Person Email
pkicinski@cozl.pl
Site Name
Instytut Hematologii I Transfuzjologii
Contact Person Name
Ewa Lech-Maranda
Contact Person Email
bad_klin@ihit.waw.pl
Site Name
Pratia S.A.
Contact Person Name
Wojciech Jurczak
Contact Person Email
wjurczak.mcm@mp.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Hematologii i Transplantologii Szpiku
Contact Person Name
Adam Witkowski
Contact Person Email
adam.wit12@gmail.com
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Oddzial Kliniczny Hematologii
Contact Person Name
Janusz Halka
Contact Person Email
januszhalka@poczta.onet.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddzial Hematologii Onkologicznej z Pododdzialem Transplantologii Klinicznej
Contact Person Name
Jacek Krzanowski
Contact Person Email
jacek.krzanowski@gmail.com
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddzial Hematologii Ogolnej
Contact Person Name
Tadeusz Robak
Contact Person Email
robaktad@csk.umed.lodz.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz.wrobel@umed.wroc.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Chorob Wewnetrzynych i Hematologii
Contact Person Name
Piotr Rzepecki
Contact Person Email
przepecki@wim.mil.pl

Sponsor

Primary sponsor

Full Name
Acerta Pharma B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
codes: [1,5]
Name
IQVIA Biotech LLC
Responsibilities
codes: [6]
Name
Pharmaceutical Product Development LLC
Responsibilities
codes: [4]
Name
Signant Health Global LLC
Responsibilities
codes: [3] and [15] (patient reported outcomes)
Name
Medidata Solutions Inc.
Responsibilities
codes: [6,7]

Third parties

  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes: [1,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: [6,7]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"codes: [1,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"codes: [15], value: Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Pharma Services Limited","duties_or_roles":"codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC (second entry)","duties_or_roles":"codes: [15], value: Patient reported outcomes","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Inseption Group LLC","duties_or_roles":"codes: [11]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Inotiv Inc.","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Molecular Pathology Laboratory Network Inc.","duties_or_roles":"codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"codes: [6]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Calquence 100 mg hard capsules
Active Substance
acalabrutinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (EU product PRD8485701; EU marketing authorisation EU/1/20/1479/001)
Investigational Product Name
BENDAMUSTINE
Active Substance
bendamustine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (scientific product ev code SCP20211730)
Investigational Product Name
RITUXIMAB
Active Substance
rituximab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (scientific product ev code SCP24437829)
Investigational Product Name
Capsule, hard (placebo)
Modality
Other
Authorisation Status
Not applicable (placebo)
Combination Treatment
Yes

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