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NCT04264806WithdrawnPhase 2

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)

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)

Source: ClinicalTrials.gov · Last updated 20 May 2022

Reason given: The cusatuzumab MDS strategy is under revision

Brief summary (registry, in English)

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).

Status (registry)
Withdrawn
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
0 (actual)
First submitted
7 Feb 2020
Start date
6 May 2021
Primary completion date
19 Apr 2022
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04264806
EudraCT number
2019-003576-40

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs), for higher-risk MDS or CMML. Prior supportive therapies including transfusion and growth factors are acceptable
  • Received prior treatment with cusatuzumab
  • Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug

Other illness

  • Any active systemic infection

Other

  • Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl) rearrangement

Who the study is looking for

  • Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016 criteria
  • At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per Revised International Prognostic Scoring System [IPSS R]) OR higher-risk CMML (intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System [CPSS-Mol]). Participants with previous lower-risk MDS or CMML that has evolved to higher-risk MDS or CMML are eligible
  • At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than (<) 3 * upper limit of normal (ULN); Total bilirubin less than or equal to (<=) 1.5 * ULN, unless bilirubin rise is due to Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater than (>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) (by Modification of Diet in Renal Disease formula)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
St Vincents Hospital SydneyDarlinghurstAustraliaUnknown status
St Vincents Hospital MelbourneFitzroyAustraliaUnknown status
Peter MacCallum Cancer InstituteMelbourneAustraliaUnknown status
Royal Perth HospitalPerthAustraliaUnknown status
Westmead HospitalWestmeadAustraliaUnknown status
Wollongong HospitalWollongongAustraliaUnknown status
Hospital Erasto Gaertner - Liga Paranaense de Combate ao CâncerCuritibaBrazilUnknown status
CEPON - Centro de Pesquisas OncologicasFlorianópolisBrazilUnknown status
Liga Norte Riograndense Contra o CancerNatalBrazilUnknown status
Instituto do cancer -COR -Hospital Mae de DeusPorto AlegreBrazilUnknown status
Hospital de Clinicas de Porto AlegrePorto AlegreBrazilUnknown status
OncoclínicasRio de JaneiroBrazilUnknown status
Hospital de Base de Sao Jose do Rio PretoSão José do Rio PretoBrazilUnknown status
Hospital PaulistanoSão PauloBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino (IDOR)São PauloBrazilUnknown status
Inselspital Universitätsspital BernBernSwitzerlandUnknown status
Hôpitaux universitaires de GenèveGenevaSwitzerlandUnknown status
Universitaetsspital ZuerichZurichSwitzerlandUnknown status
Universitatsklinikum Carl Gustav Carcus DresdenDresdenGermanyUnknown status
Universitätsklinik FreiburgFreiburg im BreisgauGermanyUnknown status
Medizinische Hochschule HannoverHanoverGermanyUnknown status
Universitatsklinikum LeipzigLeipzigGermanyUnknown status
Klinikum rechts der Isar an der Technischen Universitat MunchenMünchenGermanyUnknown status
Universitaetsklinikum UlmUlmGermanyUnknown status
Hosp. Univ. Germans Trias I PujolBadalonaSpainUnknown status
Hosp Univ Vall D HebronBarcelonaSpainUnknown status
Inst. Cat. Doncologia-H Duran I ReynalsBarcelonaSpainUnknown status
Hosp. de La Santa Creu I Sant PauBarcelonaSpainUnknown status
Hosp. Univ. Infanta LeonorMadridSpainUnknown status
Centro Integral Oncologico Clara CampalMadridSpainUnknown status
Hosp. Univ. Son EspasesPalmaSpainUnknown status
Hosp Clinico Univ de SalamancaSalamancaSpainUnknown status
Hosp. Virgen Del RocioSevilleSpainUnknown status
CHU d AngersAngersFranceUnknown status
Hopital Saint Vincent de PaulLilleFranceUnknown status
CHU de Limoges-Hopital DupuytrenLimogesFranceUnknown status
Hôpital de la ConceptionMarseilleFranceUnknown status
Chu de Nice Hopital de L'ArchetNiceFranceUnknown status
Hôpital Cochin APHPParisFranceUnknown status
Hopital Saint LouisParisFranceUnknown status
CHRU Tours Hopital BretonneauToursFranceUnknown status
CHU de Nancy_ Hopital BraboisVandœuvre-lès-NancyFranceUnknown status
St James HospitalLeedsUnited KingdomUnknown status
Kings College HospitalLondonUnited KingdomUnknown status
University College London HospitalsLondonUnited KingdomUnknown status
Royal Victoria InfirmaryNewcastle Upun TyneUnited KingdomUnknown status
Churchill HospitalOxfordUnited KingdomUnknown status
Policlinico Sant'Orsola-MalpighiBolognaItalyUnknown status
Azienda Ospedaliero - Universitaria di FerraraConaItalyUnknown status
Università del Piemonte Orientale - Ospedale Maggiore della Carità di NovaraNovaraItalyUnknown status
Aou San Luigi GonzagaOrbassanoItalyUnknown status
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio CalabriaReggio CalabriaItalyUnknown status
Policlinico Umberto IRomaItalyUnknown status
Fondazione Policlinico Tor VergataRomaItalyUnknown status
Istituto Clinico HumanitasRozzanoItalyUnknown status
Emergency Hospital of DzerzhinskDzerzhinskRussiaUnknown status
S.P. Botkin Moscow City Clinical HospitalMoscowRussiaUnknown status
Nizhniy Novgorod Region Clinical HospitalNizhny NovgorodRussiaUnknown status
Ryazan Regional Clinical HospitalRyazanRussiaUnknown status
Saint Petersburg City Hospital #15Saint PetersburgRussiaUnknown status
Clinical Research Institute of Hematology and TransfusiologySaint PetersburgRussiaUnknown status
St.-Petersburg City Clinical Hospital nr 31Saint PetersburgRussiaUnknown status
Oncology Dispensary of Komi RepublicSyktyvkarRussiaUnknown status
King Fahad Specialist HospitalDammamSaudi ArabiaUnknown status
King Abdulaziz Medical CityJeddahSaudi ArabiaUnknown status
King Faisal Specialist Hospital & Research CenterRiyadhSaudi ArabiaUnknown status
Ankara Universitesi Tip FakultesiAnkaraTürkiyeUnknown status
Gulhane Egitim ve Arastirma HastanesiAnkaraTürkiyeUnknown status
Dr. Abdurrahman Yurtaslan Oncology Training and Research HospitalAnkaraTürkiyeUnknown status
Koc Universitesi HastanesiIstanbulTürkiyeUnknown status
Dokuz Eylul Universitesi Tip FakultesiIzmirTürkiyeUnknown status
Ege Universitesi Tip FakultesiIzmirTürkiyeUnknown status
Ondokuz Mayis Universitesi Tip FakultesiSamsunTürkiyeUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.