A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 6, 2021

Primary Completion Date

April 19, 2022

Study Completion Date

January 28, 2025

Conditions
Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic
Interventions
DRUG

Azacitidine

Participants will receive subcutaneous (SC) or intravenous (IV) injection of Azacitidine 75 mg/m\^2.

DRUG

Cusatuzumab

Participants will receive SC or IV injection of Cusatuzumab 20 mg/kg.

Trial Locations (73)

1205

Hopitaux Universitaires de Geneve, Geneva

2010

St Vincents Hospital Sydney, Darlinghurst

2145

Westmead Hospital, Westmead

2500

Wollongong Hospital, Wollongong

3010

INSELSPITAL, Universitätsspital Bern, Bern

3065

St Vincents Hospital Melbourne, Fitzroy

6000

Royal Perth Hospital, Perth

7120

Hosp. Univ. Son Espases, Palma

10043

Aou San Luigi Gonzaga, Orbassano

12713

King Faisal Specialist Hospital & Research Center, Riyadh

13005

Hôpital de La Conception, Marseille

15215

King Fahad Specialist hospital, Dammam

20089

Istituto Clinico Humanitas, Rozzano

21423

King Abdulaziz Medical City, Jeddah

28031

Hosp. Univ. Infanta Leonor, Madrid

28050

Centro Integral Oncológico Clara Campal, Madrid

28100

Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara, Novara

30625

Medizinische Hochschule Hannover, Hanover

34010

Koc Universitesi Hastanesi, Istanbul

35100

Ege Universitesi Tip Fakultesi, Izmir

35340

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

37000

CHRU Tours Hôpital Bretonneau, Tours

37007

Hosp. Clinico Univ. de Salamanca, Salamanca

40138

Policlinico Sant'Orsola Malpighi, Bologna

41013

Hosp. Virgen Del Rocio, Seville

44124

Azienda Ospedaliero Universitaria di Ferrara, Cona

49933

CHU d'Angers, Angers

54500

CHU de Nancy_ Hôpital Brabois, Vandœuvre-lès-Nancy

55200

Ondokuz Mayis Universitesi Tip Fakultesi, Samsun

59020

Hopital Saint Vincent de Paul, Lille

75475

Hopital Saint-Louis, Paris

75674

Hopital Cochin APHP, Paris

79106

Universitätsklinik Freiburg, Freiburg im Breisgau

81675

Klinikum rechts der Isar an der Technischen Universität München, München

87042

CHU de Limoges, Hopital Dupuytren, Limoges

89081

Universitaetsklinikum Ulm, Ulm

89124

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria, Reggio Calabria

123182

Saint Petersburg City Hospital #15, Saint Petersburg

125284

S.P. Botkin Moscow City Clinical Hospital, Moscow

167904

Oncology Dispensary of Komi Republic, Syktyvkar

191024

Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg

197110

St.-Petersburg City Clinical Hospital nr 31, Saint Petersburg

390039

Ryazan Regional Clinical Hospital, Ryazan

603126

Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod

606019

Emergency Hospital of Dzerzhinsk, Dzerzhinsk

4501000

Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo

Unknown

Peter MacCallum Cancer Institute, Melbourne

UniversitaetsSpital Zuerich, Zurich

81520-060

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer, Curitiba

88034-000

Cepon - Centro De Pesquisas Oncologicas, Florianópolis

59062-000

Liga Norte Riograndense Contra O Cancer, Natal

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

90110-270

Instituto do cancer -COR -Hospital Mae de Deus, Porto Alegre

22250-905

Oncoclínicas, Rio de Janeiro

15090-000

Hospital de Base de São José do Rio Preto, São José do Rio Preto

01321-001

Hospital Paulistano, São Paulo

06200

CHU de Nice Hopital de l Archet, Nice

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

01307

Universitatsklinikum Carl Gustav Carcus Dresden, Dresden

04103

Universitatsklinikum Leipzig, Leipzig

00133

Fondazione Policlinico Tor Vergata, Roma

00161

Policlinico Umberto I, Roma

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08035

Hosp. Univ. Vall D Hebron, Barcelona

08041

Hosp. de La Santa Creu I Sant Pau, Barcelona

08908

Inst. Cat. Doncologia-H Duran I Reynals, Barcelona

06010

Gulhane Egitim ve Arastirma Hastanesi, Ankara

06590

Ankara Universitesi Tip Fakultesi, Ankara

LS9 7TF

St James Hospital, Leeds

NW1 2BU

University College London Hospitals, London

SE5 9RF

Kings College Hospital, London

NE1 4LP

Royal Victoria Infirmary, Newcastle Upun Tyne

OX3 7LE

Churchill Hospital, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

argenx

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY