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- Withdrawn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
Sites (73)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincents Hospital Sydney | Darlinghurst | Australia | Unknown status |
| St Vincents Hospital Melbourne | Fitzroy | Australia | Unknown status |
| Peter MacCallum Cancer Institute | Melbourne | Australia | Unknown status |
| Royal Perth Hospital | Perth | Australia | Unknown status |
| Westmead Hospital | Westmead | Australia | Unknown status |
| Wollongong Hospital | Wollongong | Australia | Unknown status |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Brazil | Unknown status |
| CEPON - Centro de Pesquisas Oncologicas | Florianópolis | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer | Natal | Brazil | Unknown status |
| Instituto do cancer -COR -Hospital Mae de Deus | Porto Alegre | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Brazil | Unknown status |
| Oncoclínicas | Rio de Janeiro | Brazil | Unknown status |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | Brazil | Unknown status |
| Hospital Paulistano | São Paulo | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo | Brazil | Unknown status |
| Inselspital Universitätsspital Bern | Bern | Switzerland | Unknown status |
| Hôpitaux universitaires de Genève | Geneva | Switzerland | Unknown status |
| Universitaetsspital Zuerich | Zurich | Switzerland | Unknown status |
| Universitatsklinikum Carl Gustav Carcus Dresden | Dresden | Germany | Unknown status |
| Universitätsklinik Freiburg | Freiburg im Breisgau | Germany | Unknown status |
| Medizinische Hochschule Hannover | Hanover | Germany | Unknown status |
| Universitatsklinikum Leipzig | Leipzig | Germany | Unknown status |
| Klinikum rechts der Isar an der Technischen Universitat Munchen | München | Germany | Unknown status |
| Universitaetsklinikum Ulm | Ulm | Germany | Unknown status |
| Hosp. Univ. Germans Trias I Pujol | Badalona | Spain | Unknown status |
| Hosp Univ Vall D Hebron | Barcelona | Spain | Unknown status |
| Inst. Cat. Doncologia-H Duran I Reynals | Barcelona | Spain | Unknown status |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | Spain | Unknown status |
| Hosp. Univ. Infanta Leonor | Madrid | Spain | Unknown status |
| Centro Integral Oncologico Clara Campal | Madrid | Spain | Unknown status |
| Hosp. Univ. Son Espases | Palma | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain | Unknown status |
| Hosp. Virgen Del Rocio | Seville | Spain | Unknown status |
| CHU d Angers | Angers | France | Unknown status |
| Hopital Saint Vincent de Paul | Lille | France | Unknown status |
| CHU de Limoges-Hopital Dupuytren | Limoges | France | Unknown status |
| Hôpital de la Conception | Marseille | France | Unknown status |
| Chu de Nice Hopital de L'Archet | Nice | France | Unknown status |
| Hôpital Cochin APHP | Paris | France | Unknown status |
| Hopital Saint Louis | Paris | France | Unknown status |
| CHRU Tours Hopital Bretonneau | Tours | France | Unknown status |
| CHU de Nancy_ Hopital Brabois | Vandœuvre-lès-Nancy | France | Unknown status |
| St James Hospital | Leeds | United Kingdom | Unknown status |
| Kings College Hospital | London | United Kingdom | Unknown status |
| University College London Hospitals | London | United Kingdom | Unknown status |
| Royal Victoria Infirmary | Newcastle Upun Tyne | United Kingdom | Unknown status |
| Churchill Hospital | Oxford | United Kingdom | Unknown status |
| Policlinico Sant'Orsola-Malpighi | Bologna | Italy | Unknown status |
| Azienda Ospedaliero - Universitaria di Ferrara | Cona | Italy | Unknown status |
| Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara | Novara | Italy | Unknown status |
| Aou San Luigi Gonzaga | Orbassano | Italy | Unknown status |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria | Reggio Calabria | Italy | Unknown status |
| Policlinico Umberto I | Roma | Italy | Unknown status |
| Fondazione Policlinico Tor Vergata | Roma | Italy | Unknown status |
| Istituto Clinico Humanitas | Rozzano | Italy | Unknown status |
| Emergency Hospital of Dzerzhinsk | Dzerzhinsk | Russia | Unknown status |
| S.P. Botkin Moscow City Clinical Hospital | Moscow | Russia | Unknown status |
| Nizhniy Novgorod Region Clinical Hospital | Nizhny Novgorod | Russia | Unknown status |
| Ryazan Regional Clinical Hospital | Ryazan | Russia | Unknown status |
| Saint Petersburg City Hospital #15 | Saint Petersburg | Russia | Unknown status |
| Clinical Research Institute of Hematology and Transfusiology | Saint Petersburg | Russia | Unknown status |
| St.-Petersburg City Clinical Hospital nr 31 | Saint Petersburg | Russia | Unknown status |
| Oncology Dispensary of Komi Republic | Syktyvkar | Russia | Unknown status |
| King Fahad Specialist Hospital | Dammam | Saudi Arabia | Unknown status |
| King Abdulaziz Medical City | Jeddah | Saudi Arabia | Unknown status |
| King Faisal Specialist Hospital & Research Center | Riyadh | Saudi Arabia | Unknown status |
| Ankara Universitesi Tip Fakultesi | Ankara | Türkiye | Unknown status |
| Gulhane Egitim ve Arastirma Hastanesi | Ankara | Türkiye | Unknown status |
| Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital | Ankara | Türkiye | Unknown status |
| Koc Universitesi Hastanesi | Istanbul | Türkiye | Unknown status |
| Dokuz Eylul Universitesi Tip Fakultesi | Izmir | Türkiye | Unknown status |
| Ege Universitesi Tip Fakultesi | Izmir | Türkiye | Unknown status |
| Ondokuz Mayis Universitesi Tip Fakultesi | Samsun | Türkiye | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.