Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

PHASE3TerminatedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

March 25, 2024

Study Completion Date

March 25, 2024

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Magrolimab

Administered intravenously (IV).

DRUG

Venetoclax

Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).

DRUG

Azacitidine

Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).

DRUG

Cytarabine

"Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days).~Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles."

DRUG

Daunorubicin

Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).

DRUG

Idarubicin

Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).

DRUG

Steroidal Eye Drops

Administered per institutional standard during consolidation.

Trial Locations (156)

2145

Westmead Hospital / Department of Haematology and Bone Marrow Transplantation, Westmead

2298

Calvary Master Newcastle, Waratah

2605

Canberra Hospital, Garran

3004

The Alfred, Melbourne

3010

Hospital General Universitario de Alicante, Alicante

3122

St Vincents Hospital Melbourne, Melbourne

3220

Andrew Love Cancer Centre, University Hospital Geelong, Geelong

4021

Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed, Linz

4031

Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin, Basel

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

Odense University Hospital, Odense C

5020

Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU, Salzburg

6000

Royal Perth Hospital, Perth

Grand Hôpital De Charleroi - Notre Dame, Charleroi

6150

Fiona Stanley Hospital, Murdoch

6200

CHU Nice - Hopital Archet 1, Nice

8000

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV, Bruges

8800

AZ Delta vzw, Roeselare

9000

Universitair Ziekenhuis Gent, Ghent

Aalborg University Hospital, Aalborg

10001

Complejo Hospitalario San Pedro de Alcantara, Cáceres

10032

Columbia University Medical Center - Herbert Irving Pavilion, New York

10122

SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino, Torino

13009

Institut Paoli Calmettes, Marseille

13353

Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum, Berlin

14004

Hospital Universitario Reina Sofia, Córdoba

14033

CHU de Caen, Caen

14263

Roswell Park Cancer Institute, Buffalo

19107

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia

20246

Dept. of Medicine II, University Hospital Hamburg-Eppendorf, Hamburg

21100

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi, Varese

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

24105

Universitatsklinikum Schleswig-Holstein, Kiel

27599

UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill

27705

Duke Blood Cancer Center, Durham

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center Madrid, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

29607

St. Francis Cancer Center, Greenville

29615

Prisma Health Cancer Institute, Greenville

30322

Winship Cancer Institute, Atlanta

31008

Clinica Universidad de Navarra - Pamplona (Main Site), Pamplona

31059

IUCT Oncopole, Toulouse

32224

Mayo Clinic Florida, Jacksonville

32804

AdventHealth Orlando, Orlando

33011

Hospital Universitario Central de Asturias, Oviedo

33028

Memorial Cancer Institute, Pembroke Pines

33176

Miami Cancer Institute, Miami

33604

Hopital Haut-Leveque, Pessac

33612

Moffitt Cancer Center, Tampa

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria

35294

University of Alabama at Birmingham, Birmingham

37007

Complejo Asistencial Universitario de Salamanca - Hsopital Clinico, Salamanca

38114

Department of Hematology and Oncology, Braunschweig Community Hospital, Braunschweig

39008

Hospital U. Marques de Valdecilla, Santander

40138

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia, Bologna

40174

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRS - Oncologia Medica", Meldola

40225

Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie, Düsseldorf

40536

University of Kentucky Medical Center, Lexington

43210

The Ohio State University Wexner Medical Center/ James Cancer Hospital, Columbus

44093

CHU de Nantes, Hotel Dieu, Nantes

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari I Politècnic La Fe, Valencia

49933

CHU d'Angers, Angers

50937

Universitatsklinikum Koln, Cologne

52074

Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation, Aachen

53226

Froedtert Hospital / Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester

59037

CHRU Lille - Hospital Claude Huriez, Lille

60611

Northwestern Memorial Hospital/Main Lab, Chicago

60637

The University of Chicago Medical Centre, Chicago

61122

"AORM - AO Riuniti Marche Norde - Pesaro Presidio San Salvatore - Muraglia", Pesaro

63110

SSM Health Saint Louis University Hospital, St Louis

64132

MidAmerica Division, Inc., c/o Research Medical Center, Kansas City

66205

University of Kansas Hospital, Fairway

67063

Klinikum Ludwigshafen Medizinische Klinik A, Ludwigshafen

69120

Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie, Heidelberg

69495

Central Hospital Lyon Sud, Lyon

70112

Tulane Medical center, New Orleans

70124

AOU Consorziale Policlinico Bari, Bari

73104

University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center, Oklahoma City

77030

Baylor College of Medicine Medical Center, Houston

The University of Texas MD Anderson Cancer Center, Houston

80131

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo, Napoli

80218

Colorado Blood Cancer Institute, Denver

81377

LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern, München

81675

Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III, München

84112

Huntsman Cancer Institute ,The University of Utah, Salt Lake City

87042

CHU Limoges, Limoges

89081

Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III, Ulm

90033

USC/ Norris Comprehensive Cancer Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center, Los Angeles

91010

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte

92868

UC Irvine Health, Orange

94805

Gustave Roussy, Paris

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

Unknown

Universitair Ziekenhuis Brussel, Brussels

Universitaire Ziekenhuis Antwerpen, Edegem

Hopitaux de Brabois, Vandœuvre-lès-Nancy

Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong

Queen Mary Hospital, Hong Kong

T2N 4N2

Tom Baker Cancer Center, Calgary

B3H 1V7

Queen Elizabeth II Health Sciences Centre, Halifax

H1T 2M4

CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont, Montreal

H4A 3J1

McGill University Health Centre, Montreal

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

01307

Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie, Dresden

I-60126

Azienda Ospedaliero Universitaria delle Marche, Ancona

06129

SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia, Perugia

00133

Fondazione PTV Policinico Tor Vergata, Roma

660-8550

Hyogo Prefectural Amagasaki General Medical Center, Amagasaki

260-0852

Chiba Aoba Municipal Hospital, Chiba

409-3898

University of Yamanashi Hospital, Chūō

812-8582

Kyushu University Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

064-0804

Aiiku Hospital, Hokkaido

259-1193

Tokai University School of Medicine, Isehara

920-8641

Kanazawa University Hospital, Kanazawa

277-8577

National Cancer Center Hospital East, Kashiwa

807-8555

Hospital of the University of Occupational and Environmental Health, Japan, Kitakyushu-shi

650-0047

Kobe City Medical Center General Hospital, Kobe

371-0821

Gunmaken Saiseikai Maebashi Hospital, Maebashi

790-0024

Ehime Prefectural Center Hospital, Matsuyama

852-8501

Nagasaki University Hospital, Nagasaki

453-8511

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya

466-8650

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya

700-8558

Okayama University Hospital, Okayama

545-8586

Osaka Metropolitan University Hospital, Osaka

589-8511

Kindai University Hospital, Sayama

980-8574

National University Corporation Tohoku University Tohoku University Hospital, Sendai

141-8625

NTT Medical Center Tokyo, Shinagawa-Ku

990-9585

Yamagata University Hospital, Yamagata

910-1193

University of Fukui Hospital, Yoshida-gun

08025

Hospital del la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08907

Institut Catala d'Oncologia, Barcelona

09006

Complejo Asistencial Universitario de Burgos/H.U. de Burgos, Burgos

221 85

Universitetssjukhus, Hematologimottagnungen, Lund

CH 3010

Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie, Bern

B15 2GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

PE21 9QS

United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road, Boston

CB2 0QQ

Cambridge University Hospital NHS Foundation Trust, Cambridge

CF14 4XW

Cardiff and Vale University Health Board, Cardiff Wales

EC1A 7BE

Barts Health NHS Trust, City of London

DD1 9SY

NHS Tayside, Dundee

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

SE5 9RS

King's College NHS Foundation Trust, London

OX3 7LE

Oxford University Hospital NHS Foundation Trust, Oxford

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

M20 4BX

The Christie NHS Foundation Trust, Withington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY