Myelodysplastic Syndrome Clinical Trial

A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Summary

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Body weight >= 40 kg at screening.
Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
Willingness and ability to comply with all study visits and procedures.
Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration.
Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).

Exclusion Criteria:

History of allogeneic bone marrow transplantation.
History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment.
Positive for Active Hepatitis B and C infection (HBV/HCV).
Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study.
History of or ongoing cryoglobulinemia at screening.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT04432584

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 112 Locations for this study

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The Oncology Institute of Hope and Innovation
Anaheim California, 92801, United States
Indiana Blood & Marrow Transplantation, LLC
Indianapolis Indiana, 46237, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Carolinas Healthcare System
Charlotte North Carolina, 28208, United States
Nationwide Children's Hospital; Dept. of Pulmonology
Columbus Ohio, 43205, United States
Cook Childrens Medical Center
Fort Worth Texas, 76104, United States
Liverpool Hospital
Sydney New South Wales, 2080, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Cliniques Universitaires Saint-Luc; Pharmacy
Bruxelles , 1200, Belgium
AZ Delta Campus Westlaan
Roeselare , 8800, Belgium
CHU UCL Namur / site Godinne
Yvoir , B5530, Belgium
Hospital Universitario Walter Cantidio - UFC
Fortaleza CE, 60430, Brazil
Nucleo de Pesquisa Clinica do Hospital da Crianca
Brasilia DF, 70684, Brazil
Chronos Pesquisa Clinica
Taguatinga DF, 72145, Brazil
Elo Clinical Research
Maringa PA, 87015, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba PR, 80810, Brazil
Hrpc - Health Clinical Research Representation - Eireli
Canoas RS, 92010, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre RS, 90050, Brazil
Hospital de Clínicas de Porto Alegre X
Porto Alegre RS, , Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville SC, 89201, Brazil
Fundação Doutor Amaral Carvalho
JAU SP, 17210, Brazil
Hospital das Clínicas FMRP-USP
Ribeirao Preto SP, 14048, Brazil
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André SP, 09060, Brazil
Hospital Sírio-Libanês
Sao Paulo SP, 01308, Brazil
Hospital Paulistano
Sao Paulo SP, 01321, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo SP, 01321, Brazil
CISSS Chaudière-Appalaches
Levis Quebec, G6V 3, Canada
Ustav hematologie a krevni transfuze
Praha , 128 0, Czechia
North Estonia Medical Centre Foundation
Tallinn , 13419, Estonia
Hopital Claude Huriez - CHU Lille
Lille , 59037, France
Institut Paoli Calmette; Service d'Hématologie Clinique
Marseille , 13273, France
CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique
Rennes cedex 9 , 35033, France
Universitaetsklinikum Aachen AOeR
Aachen , 52074, Germany
Universitaetsklinikum
Essen , 45147, Germany
Universitaetsklinikum Ulm
Ulm , 89081, Germany
University General Hospital of Alexandroupolis
Alexandroupolis , 681 0, Greece
Attikon University General Hospital
Chaidari , 124 6, Greece
University General Hospital of Larissa
Larissa , 412 2, Greece
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki , 57010, Greece
General Hospital of Athens LAIKO
Αθηνα , 115 2, Greece
The Chinese University of Hong Kong
Shatin , 12345, Hong Kong
Semmelweis Egyetem
Budapest , 1088, Hungary
St James's Hospital; Haematology
Dublin , D08 N, Ireland
Azienda Ospedaliera San Giuseppe Moscati
Avellino Campania, 83100, Italy
Azienda Unita Sanitaria Locale- Ravenna
Ravenna Emilia-Romagna, 48100, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma Lazio, 00168, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano Molise, 20122, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino Piemonte, 10126, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania Sicilia, 95123, Italy
Azienda Ospedaliera Universitaria Careggi
Florence Toscana, 50134, Italy
Fujita Health University Hospital
Aichi , 470-1, Japan
Fukushima Medical University Hospital
Fukushima , 960-1, Japan
Sapporo Medical University Hospital
Hokkaido , 060-8, Japan
Kobe University Hospital; Medical Oncology and Hematology
Hyogo , 650-0, Japan
Okinawa Tokushukai Takasago Seibu Hospital
Hyogo , 676-0, Japan
University of Tsukuba Hospital
Ibaraki , 305-8, Japan
Ishikawa Prefectural Central Hospital
Ishikawa , 920-8, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Mie University Hospital
Mie , 514-8, Japan
Japanese Red Cross Society Suwa Hospital
Nagano , 392-8, Japan
Nagasaki University Hospital
Nagasaki , 852-8, Japan
Sasebo City General Hospital
Nagasaki , 857-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Iwate Prefectural Isawa Hospital
Oshu , 023-0, Japan
NTT Medical Center Tokyo
Tokyo , 141-8, Japan
Tokyo Medical University Hospital
Tokyo , 160-0, Japan
Toyama Prefectual Central Hospital
Toyama , 930-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital; Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Amsterdam UMC, Locatie AMC
Amsterdam , 1105 , Netherlands
Szpital Uniwersytecki nr2 im. dr J. Biziela
Bydgoszcz , 85-16, Poland
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk , 80-95, Poland
SPZOZ Szpital Uniw W Krakowie
Krakow , 31-50, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin , 20-08, Poland
Centrum Medyczne Pratia Poznan
Skórzewo , 60-18, Poland
MTZ Clinical Research Powered by Pratia
Warszawa , 02-17, Poland
Centro Hospitalar do Porto - Hospital de Santo António
Porto , 4099-, Portugal
King Faisal Specialist Hospital & Research Center
Riyadh , 12713, Saudi Arabia
National University Hospital
Singapore , 11759, Singapore
ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica
Badalona Barcelona, 08916, Spain
Hospital Sant Joan De Deu
Esplugues De Llobregas Barcelona, 08950, Spain
Complejo Hospitalario Universitario de Santiago.
Santiago de Compostela LA Coruña, 5ºA, Spain
Hospital Universitario de Gran Canaria
Las Palmas de Gran Canaria LAS Palmas, 35019, Spain
Hospital de Basurto
Bilbao Vizcaya, 48013, Spain
Hospital U. Central de Asturias
Asturias , 33011, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital San Pedro de Alcantara
Caceres , 10003, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario Clinico San Carlos
Madrid , 28040, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Complejo Hospitalario de Toledo
Toledo , 45004, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Changhua Christian Hospital
Chang Hua , 500, Taiwan
Hualien Tzu Chi Hospital; Hematology and oncology
Hualien City , 97002, Taiwan
Chi Mei Medical Center Liou Ying Campus
Liuying Township , 736, Taiwan
National Taiwan Universtiy Hospital; Division of Hematology
Taipei , 100, Taiwan
MacKay Memorial Hospital; Hematology and oncology
Zhongshan Dist. , 10449, Taiwan
Hacettepe University Medical Faculty; Neurology
Ankara , 06100, Turkey
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology
Gaziantep , 27310, Turkey
Istanbul University Istanbul Medical Faculty; Neurology
Istanbul , 34093, Turkey
Marmara University Pendik Training and Research Hospital, Hematology Department
Istanbul , 34300, Turkey
Ege University Medical Faculty; Hematology
Izmir , 35100, Turkey
Ondokuz Mayis Univ. Med. Fac.
Samsun , 55139, Turkey
King'S College Hospital; Haematology
London , SE5 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT04432584

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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