Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

March 18, 2021

Study Completion Date

June 30, 2026

Conditions
Newly Diagnosed Acute Myeloid Leukemia (AML)Untreated AMLAML Arising From Myelodysplastic Syndrome (MDS)Leukemia, Myeloid, Acute
Interventions
DRUG

AG-120

Tablets administered orally

DRUG

Placebo

Tablets administered orally

DRUG

Azacitidine

Administered SC or IV

Trial Locations (90)

500

Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua

736

Chi Mei Medical Center, Liouying, Tainan City

807

Kaohsiung Medical University Hospital, Kaohsiung City

1130

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna

2050

Royal Prince Alfred Hospital, Camperdown

5000

Royal Adelaide Hospital, Adelaide

5020

Salzburger Landeskliniken, Salzburg

5042

Flinders Medical Centre, Bedford Park

10126

Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino

10408

National Cancer Center, Goyang-si

13353

Charite - Universitatsmedizin Berlin, Berlin

14000

Institut dHematologie de Basse Normandie, Caen

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, México

15706

CHUS H. Clinico U. de Santiago, Santiago de Compostela

16499

Ajou University Hospital, Suwon

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milan

21100

ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi, Varese

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29609

CHRU de Brest - Hopital Morvan, Brest

30625

Medizinische Hochschule Hannover, Hanover

31059

EDOG - Institut Claudius Regaud - PPDS, Toulouse

33604

Hopital Haut Leveque, Pessac

35010

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

37044

Hopital Bretonneau, Tours

38043

CHU de Grenoble, Grenoble

40207

Norton Cancer Institute - Suburban, Louisville

40447

China Medical University Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio - PPDS, Seville

44093

Hotel Dieu - Nantes, Nantes

45122

Universitatsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola

47900

Ospedale Infermi di Rimini, Rimini

49100

Rabin Medical Center - PPDS, Petah Tikva

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

67200

Hopital de Hautepierre, Strasbourg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70300

Shamir Medical Center Assaf Harofeh, Tzrifin

72037

Centre Hospitalier Le Mans, Le Mans

75015

Groupe Hospitalier Necker Enfants Malades, Paris

80230

SINACOR, Culiacán

81377

LMU Klinikum der Universitat Munchen, München

86021

CHRU de Poitiers La Miletrie, Poitiers

89081

Universitatsklinikum Ulm, Ulm

94805

Institut Gustave Roussy, Villejuif

129301

City Clinical Hospital # 40, Moscow

248007

Kaluga Regional Clinical Hospital, Kaluga

300020

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin

310003

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

450008

Henan Cancer Hospital, Zhengzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

610041

West China Hospital Sichuan University, Chengdu

7610000

Kaplan Medical Center, Rehovot

02114

Massachusetts General Hospital, Boston

13083-878

Unicamp Universidade Estadual de Campinas, Campinas

17210-120

Hospital Amaral Carvalho, Jaú

20230-130

Instituto Nacional de Cancer, Rio de Janeiro

01308-050

Hospital Sirio Libanes, São Paulo

01321-001

Hospital Sao Jose, São Paulo

08270-070

Hospital Santa Marcelina, São Paulo

R3E 0V9

Cancer Care Manitoba, Winnipeg

M5G 2M9

University Health Network, Toronto

Unknown

Peking Union Medical College Hospital, Beijing

Fakultni nemocnice Ostrava, Ostrava

Kobe City Medical Center General Hospital, Kobe

National Taiwan University Hospital, Taipei

78 157

Centre Hospitalier de Versailles CHV Hopital Andre Mignot, Le Chesnay

09113

Klinikum Chemnitz gGmbH, Chemnitz

04103

Universitatsklinikum Leipzig, Leipzig

790-8524

Matsuyama Red Cross Hospital, Matsuyama

910-1193

University of Fukui Hospital, Fukui

670-8540

Japanese Red Cross Society Himeji Hospital, Himeji

1081 HV

VU Medisch Centrum, Amsterdam

6525 GA

Universitair Medisch Centrum Groningen, Nijmegen

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

602-739

Pusan National University Hospital, Busan

03722

Severance Hospital Yonsei University Health System, Seoul

110-744

Seoul National University Hospital, Seoul

07010

Hospital Universitario Son Espases, Palma de Mallorca

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

B9 5SS

Birmingham Heartlands Hospital, Birmingham

All Listed Sponsors
lead

Institut de Recherches Internationales Servier

OTHER