A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

July 29, 2019

Primary Completion Date

August 15, 2023

Study Completion Date

May 15, 2026

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Azacitidine

Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle.

DRUG

Cusatuzumab

Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.

Trial Locations (56)

1205

Hopitaux Universitaires de Geneve, Geneva

2010

St Vincents Hospital Sydney, Darlinghurst

2145

Westmead Hospital, Westmead

3004

The Alfred Hospital, Melbourne

3010

INSELSPITAL, Universitätsspital Bern, Bern

3065

St Vincents Hospital Melbourne, Fitzroy

5001

Kantonsspital Aarau, Aarau

6000

Royal Perth Hospital, Perth

6100

Ankara University Medical Faculty Hematology Department - Hematology, Ankara

7120

Hosp. Univ. Son Espases, Palma

8035

Hosp. Univ. Vall D Hebron, Barcelona

13273

Institut Paoli Calmettes, Marseille

14004

Hosp. Reina Sofia, Córdoba

20141

Istituto Europeo di Oncologia, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

25123

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28223

Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón

31059

Institut Universitaire du Cancer Toulouse Oncopole, Toulouse

31096

Rambam Medical Center, Haifa

33100

Azienda Sanitaria Universitaria Integrata di Udine, Udine

33600

Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie, Pessac

34098

Istanbul Egitim ve Arastirma Hastanesi, Istanbul

35210

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

37000

CHRU Tours Hôpital Bretonneau, Tours

37007

Hosp. Clinico Univ. de Salamanca, Salamanca

38043

CHU Grenoble, Grenoble

40138

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna

46026

Hosp. Univ. I Politecni La Fe, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

49933

CHU d'Angers, Angers

55139

Ondokuz Mayis Universitesi Tip Fakultesi, Samsun

61080

Karadeniz Teknik University Medical Faculty, Trabzon

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69495

CHU Lyon Sud, Pierre-Bénite

80131

Division of Hematology, Cardarelli Hospital, Napoli

125284

S.P. Botkin Moscow City Clinical Hospital, Moscow

129301

City Clinical Hospital # 40, Moscow

167904

Komi Republic Oncology dispensary, Syktyvkar

193024

St.-Petersburg Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg

198205

City clinical hospital #15, Saint Petersburg

354057

Oncologic Dispensary No.2, Sochi

390039

Ryazan Regional Clinical Hospital, Ryazan

443095

Samara Region Clinical Hospital, Samara

454076

Chelyabinck Regional Clinical Hospital, Chelyabinsk

603126

Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod

620137

Ekaterinburg City Clinical Hospital # 7, Yekaterinburg

9112001

Hadassah Medical Center, Jerusalem

13083-878

Universidade Estadual De Campinas, Campinas

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08908

Inst. Cat. Doncologia-H Duran I Reynals, Barcelona

Unknown

UniversitaetsSpital Zuerich, Zurich

06010

Gulhane Egitim ve Arastirma Hastanesi, Ankara

06200

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

argenx

INDUSTRY

collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

OncoVerity, Inc.

INDUSTRY