A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Azacitidine: Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle.
Cusatuzumab: Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.
Study summary
The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Complete Remission (CR) — Up to 3 years and 5 months
Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L
Trial sites (56)
| Facility | City | Region | Status |
|---|---|---|---|
| St Vincents Hospital Sydney | Darlinghurst | Australia | |
| St Vincents Hospital Melbourne | Fitzroy | Australia | |
| The Alfred Hospital | Melbourne | Australia | |
| Royal Perth Hospital | Perth | Australia | |
| Westmead Hospital | Westmead | Australia | |
| Universidade Estadual De Campinas | Campinas | Brazil | |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | Brazil | |
| CHU d'Angers | Angers | France | |
| CHU Grenoble | Grenoble | France | |
| Institut Paoli Calmettes | Marseille | France | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie | Pessac | France | |
| CHU Lyon Sud | Pierre-Bénite | France | |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | France | |
| CHRU Tours Hôpital Bretonneau | Tours | France | |
| Rambam Medical Center | Haifa | Israel | |
| Hadassah Medical Center | Jerusalem | Israel | |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | |
| Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna | Bologna | Italy | |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | Italy | |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Italy | |
| Istituto Europeo di Oncologia | Milan | Italy | |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | |
| Division of Hematology, Cardarelli Hospital | Naples | Italy | |
| Azienda Sanitaria Universitaria Integrata di Udine | Udine | Italy | |
| Chelyabinck Regional Clinical Hospital | Chelyabinsk | Russia | |
| S.P. Botkin Moscow City Clinical Hospital | Moscow | Russia | |
| City Clinical Hospital # 40 | Moscow | Russia | |
| Nizhniy Novgorod Region Clinical Hospital | Nizhny Novgorod | Russia | |
| Ryazan Regional Clinical Hospital | Ryazan | Russia | |
| St.-Petersburg Clinical Research Institute of Hematology and Transfusiology | Saint Petersburg | Russia | |
| City clinical hospital #15 | Saint Petersburg | Russia | |
| Samara Region Clinical Hospital | Samara | Russia | |
| Oncologic Dispensary No.2 | Sochi | Russia | |
| Komi Republic Oncology dispensary | Syktyvkar | Russia | |
| Ekaterinburg City Clinical Hospital # 7 | Yekaterinburg | Russia | |
| Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón | Madrid | |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | Spain | |
| Inst. Cat. Doncologia-H Duran I Reynals | Barcelona | Spain | |
| Hosp. Univ. Vall D Hebron | Barcelona | Spain | |
| Hosp. Reina Sofia | Córdoba | Spain |
+ 16 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04023526 on ClinicalTrials.gov ↗ ← All trials in Turkey