Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase 2, Randomized, Open-label 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)
Study ID: NCT04264806
Study Description
Brief Summary: The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).
Detailed Description: Cusatuzumab (also known as JNJ-74494550 and ARGX-110) is a humanized monoclonal antibody of camelid origin that binds with high affinity to human Cluster of Differentiation 70 (CD70). Azacitidine (an Hypomethylating agent \[HMA\]) is approved for the treatment of higher-risk MDS in the United States (US) and the European Union (EU). Both approvals are based on data showing decreased transfusion burden, delayed progression to acute myeloid leukemia (AML), improved quality of life, and extended survival. It is hypothesized that the addition of cusatuzumab to azacitidine will result in an improvement in overall response rate (ORR) compared with azacitidine alone in participants with higher-risk MDS or CMML.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St Vincents Hospital Sydney, Darlinghurst, , Australia
St Vincents Hospital Melbourne, Fitzroy, , Australia
Peter MacCallum Cancer Institute, Melbourne, , Australia
Royal Perth Hospital, Perth, , Australia
Westmead Hospital, Westmead, , Australia
Wollongong Hospital, Wollongong, , Australia
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer, Curitiba, , Brazil
Cepon - Centro De Pesquisas Oncologicas, Florianopolis, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
Instituto do cancer -COR -Hospital Mae de Deus, Porto Alegre, , Brazil
Oncoclínicas, Rio De Janeiro, , Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, , Brazil
Hospital Paulistano, São Paulo, , Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
CHU d'Angers, Angers, , France
Hopital Saint Vincent de Paul, Lille, , France
CHU de Limoges, Hopital Dupuytren, Limoges, , France
Hôpital de La Conception, Marseille, , France
CHU de Nice Hopital de l Archet, Nice, , France
Hopital Saint-Louis, Paris Cedex 10, , France
Hopital Cochin APHP, Paris, 75, , France
CHRU Tours Hôpital Bretonneau, Tours, , France
CHU de Nancy_ Hôpital Brabois, Vandoeuvre Les Nancy, , France
Universitatsklinikum Carl Gustav Carcus Dresden, Dresden, , Germany
Universitätsklinik Freiburg, Freiburg Im Breisgau, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Klinikum rechts der Isar an der Technischen Universität München, München, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliero Universitaria di Ferrara, Cona, , Italy
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara, Novara, , Italy
Aou San Luigi Gonzaga, Orbassano, , Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria, Reggio Calabria, , Italy
Fondazione Policlinico Tor Vergata, Roma, , Italy
Policlinico Umberto I, Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Emergency Hospital of Dzerzhinsk, Dzerzhinsk, , Russian Federation
S.P. Botkin Moscow City Clinical Hospital, Moscow, , Russian Federation
Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
Saint Petersburg City Hospital #15, Saint-Petersburg, , Russian Federation
Clinical Research Institute of Hematology and Transfusiology, St-Petersburg, , Russian Federation
St.-Petersburg City Clinical Hospital nr 31, St. Petersburg, , Russian Federation
Oncology Dispensary of Komi Republic, Syktyvkar, , Russian Federation
King Fahad Specialist hospital, Dammam, , Saudi Arabia
King Abdulaziz Medical City, Jeddah, , Saudi Arabia
King Faisal Specialist Hospital & Research Center, Riyadh, , Saudi Arabia
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, , Spain
Hosp. Univ. Infanta Leonor, Madrid, , Spain
Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hosp. Univ. Son Espases, Palma, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
INSELSPITAL, Universitätsspital Bern, Bern, , Switzerland
Hopitaux Universitaires de Geneve, Geneve, , Switzerland
UniversitaetsSpital Zuerich, Zürich, , Switzerland
Gulhane Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi, Ankara, , Turkey
Koc Universitesi Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi, Izmir, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Izmir, , Turkey
Ondokuz Mayis Universitesi Tip Fakultesi, Samsun, , Turkey
St James Hospital, Leeds, , United Kingdom
University College London Hospitals, London, , United Kingdom
Kings College Hospital, London, , United Kingdom
Royal Victoria Infirmary, Newcastle Upun Tyne, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical trials
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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