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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines those who are "not candidates for intensive chemotherapy":
1. greater than or equal to (\>=)75 years of age or
2. less than (\<) 75 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2; Severe cardiac comorbidity defined as congestive heart failure or ejection fraction less than or equal to (\<=) 50 percent (%); Severe pulmonary comorbidity defined as documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) \<=65% of expected, or forced expiratory volume in 1 second (FEV1) \<=65% of expected or dyspnea at rest requiring oxygen; Moderate hepatic impairment defined according to NCI organ dysfunction classification criteria (total bilirubin \>=1.5 up to 3 times upper limit of normal \[ULN\]); Creatinine clearance \<45 milliliter per minute per 1.73 meter square (mL/ min/1.73 m\^2); Comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
* De novo or secondary AML
* Previously untreated AML (except: emergency leukapheresis, hydroxyurea, and/or 1 dose of cytarabine \[example: 1-2 gram per meter square {g/m\^2}\] during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued \>=24 hours prior to start of study drug). Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued \>=24 hours prior to the start of study drug
* Not eligible for an allogeneic hematopoietic stem cell transplantation
* ECOG Performance Status score of 0, 1 or 2
Exclusion Criteria:
* Acute promyelocytic leukemia
* Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
* Use of immune suppressive agents for the past 4 weeks before the first administration of cusatuzumab on Cycle 1 Day 3. For regular use of systemic corticosteroids, participants may only be included if free of systemic corticosteroids for a minimum of 5 days before the first administration of cusatuzumab. Treatment of adrenal insufficiency with physiologic replacement doses of corticosteroids are allowed
* Prior treatment with a hypomethylating agent for treatment of AML or myelodysplastic syndrome (MDS)
* Active malignancies (that is, progressing or requiring treatment in the last 24 months) other than the disease being treated under the study
* Any active systemic infection
* Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (that is, mannitol, an excipient of azacitidine)
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.
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.
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