A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

May 23, 2017

Primary Completion Date

February 15, 2019

Study Completion Date

August 21, 2025

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Placebo

tablet

DRUG

Venetoclax

tablet

DRUG

Cytarabine

Subcutaneous injection

Trial Locations (109)

1083

Semmelweis Egyetem I. Belklini /ID# 158180, Budapest

1097

Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127, Budapest IX

1200

Cliniques Universitaires Saint Luc /ID# 159567, Woluwe-Saint-Lambert

1431

Cemic /Id# 159676, Buenos Aires

1714

Sykehuset Ostfold Kalnes /ID# 165632, Grålum

2025

Middlemore Clinical Trials /ID# 160131, Auckland

2145

Westmead Hospital /ID# 160121, Westmead

2298

Calvary Mater Newcastle /ID# 160123, Waratah

2650

Universitair Ziekenhuis Antwerpen /ID# 159566, Edegem

3004

Alfred Hospital /ID# 160125, Melbourne

3128

Box Hill Hospital /ID# 162920, Melbourne

4032

Debreceni Egyetem Klinikai Koz /ID# 158178, Debrecen

5000

Sanatorio Allende /ID# 159675, Córdoba

5021

Haukeland University Hospital /ID# 165630, Bergen

6000

Bacs-Kiskun Megyei Korhaz /ID# 160973, Kecskemét

7400

Kaposi Mor Oktato Korhaz /ID# 158175, Kaposvár

7624

Pecsi Tudomanyegyetem /ID# 163161, Pécs

9023

Petz Aladar Megyei Oktato Korh /ID# 161739, Győr

10002

National Taiwan Univ Hosp /ID# 162781, Taipei City

10676

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869, Athens

10967

Vivantes Klinikum Am Urban /ID# 159569, Berlin

11490

Tri-Service General Hospital /ID# 161683, Taipei City

14080

Instituto Nacional de Cancerol /ID# 159269, Mexico City

15232

Univ of Pittsburgh Med Ctr /ID# 158997, Pittsburgh

20246

Universitaetsklinikum Hamburg /ID# 161760, Hamburg

26504

University Gen Hosp of Patra /ID# 157871, Pátrai

28031

Hospital Infanta Leonor /ID# 161180, Madrid

33600

CHU Bordeaux /ID# 159704, Pessac

33612

H. Lee Moffit Cancer Center /ID# 164273, Tampa

35015

Chungnam National University Hospital /ID# 158726, Junggu

41002

saratov state medical /ID# 163130, Saratov

46026

Hospital Universitario y Politecnico La Fe /ID# 161181, Valencia

54511

CHU De Nancy /ID# 159700, Vandœuvre-lès-Nancy

54601

Gundersen Health System /ID# 164272, La Crosse

57010

General Hospital of Thessaloniki George Papanikolaou /ID# 157867, Thessaloniki

58260

Centro de Invest Clin Chapulte /ID# 162625, Morelia

64100

Centre Hospitalier de la Cote /ID# 159697, Bayonne

64320

Hosp. Univ. Dr. Jose E. Gonz /ID# 159268, Monterrey

68100

Gen Univ Hosp Alexandroupolis /ID# 157868, Alexandroupoli

69495

Centre Hospitalier Lyon Sud /ID# 159705, Pierre-Bénite

72037

Centre Hospitalier Le Mans /ID# 159702, Le Mans

77030

Univ TX, MD Anderson /ID# 159678, Houston

78052

Schwarzwald-Baar-Klinikum /ID# 159571, Villingen-Schwenningen

80708

Kaohsiung Medical University /ID# 161693, Kaohsiung City

98104

Swedish Medical Center /ID# 161280, Seattle

100041

Akita University Hospital /ID# 160602, Akita

125284

City Clinical Hospital Botkina /ID# 164086, Moscow

130021

The First Hosp of Jilin Univ /ID# 167512, Changchun

150062

Yaroslavl Regional Clinic Hosp /ID# 162172, Yaroslavl

197341

Almazov North-West Federal Med /ID# 162170, Saint Petersburg

198205

Saint Petersburg State Institu /ID# 162171, Saint Petersburg

200025

Ruijin Hospital, Shanghai Jiaotong /ID# 167325, Shanghai

210029

Jiangsu Province People's Hospital /ID# 167511, Nanjing

250014

Qilu Hospital of Shandong Univ /ID# 167507, Jinan

300020

Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509, Tianjin

310003

The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324, Hangzhou

350001

Fujian Medical Univ Union Hosp /ID# 167321, Fuzhou

390039

State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126, Ryazan

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515, Wuhan

443099

Samara State Medical Universit /ID# 164173, Samara

450008

Henan Cancer Hospital /ID# 167327, Zhengzhou, Henan

510515

Nanfang Hospital of Southern Medical University /ID# 170147, Guangzhou

603126

Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186, Nizhny Novgorod

610041

West China Hospital /ID# 167514, Chengdu

650066

Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991, Kemerovo

3113193

National Hospital Organization Mito Medical Center /ID# 162988, Higashi Ibaraki-gun

40202-3700

Norton Cancer Institute /ID# 158998, Louisville

88034-000

Centro de Pesquisas Oncologicas /ID# 163567, Florianópolis

14784-400

Hospital de Cancer de Barretos /ID# 163568, Barretos

90470-150

Hospital do Cancer Mae de Deus /ID# 163416, Porto Alegre

08270-070

Casa de Saúde Santa Marcelina /ID# 163413, São Paulo

T6G 2G3

University of Alberta Hospital /ID# 159646, Edmonton

J4V 2H1

CISSS de la Monteregie /ID# 159782, Greenfield Park

H1T 2M4

Hospital Maisonneuve-Rosemont /ID# 159780, Montreal

H4J 1C5

Hopital Sacre Coeur Montreal /ID# 160982, Montreal

625 00

Fakultni Nemocnice Brno /ID# 159247, Brno

708 52

Univ Hosp Ostrava-Poruba /ID# 159246, Ostrava

100 34

Fakult Nem Kralovske Vinohrady /ID# 159248, Prague

115 27

General Hospital of Athens Laiko /ID# 157870, Athens

D08 E9P6

St. James's Hospital /ID# 162730, Dublin

D09 XR63

Beaumont Hospital /ID# 162733, Dublin

H91 YR71

University Hospital Galway /ID# 162734, Galway

V94F858

University Hospital Limerick /ID# 162735, Limerick

910-1193

University of Fukui Hospital /ID# 159770, Yoshida-gun

812-8582

Kyushu University Hospital /ID# 159688, Fukuoka

371-0821

Gunmaken Saiseikai Maebashi Hospital /ID# 160597, Maebashi

602-8566

Kyoto Prefect Univ Med /ID# 160101, Kyoto

980-8574

Tohoku University Hospital /ID# 161151, Sendai

852-8501

Nagasaki University Hospital /ID# 160233, Nagasaki

545-0051

Osaka City University Hospital /ID# 159722, Osaka

589-8511

Kinki University -Osakasayama Campus /ID# 160777, Osakasayama-shi

113-8677

Tokyo Metropolitan Komagome Hospital /ID# 160759, Bunkyo-ku

201-8601

Tokyo Jikei Daisan Hospital /ID# 159769, Komae-shi

141-8625

NTT Medical Center Tokyo /ID# 160678, Shinagawa-ku

990-9585

Yamagata University Hospital /ID# 161223, Yamagata

350-1241

Saitama Med Univ Int Med Ctr /ID# 161308, Hidaka

460-0001

NHO Nagoya Medical Center /ID# 159768, Nagoya

321-0293

Dokkyo Medical University Hosp /ID# 159650, Shimotsuga

113-8431

Juntendo University Hospital /ID# 159781, Tokyo

0622

North Shore Hospital /ID# 160132, Auckland

00921-3201

VA Caribbean Healthcare System /ID# 158999, San Juan

0001

Netcare Pretoria East Hospital /ID# 157373, Pretoria

Tshwane District Hospital /ID# 157361, Pretoria

602-739

Pusan National University Hosp /ID# 158725, Busan

06591

Cath Univ Seoul St Mary's Hosp /ID# 158724, Seoul

03080

Seoul National University Hospital /ID# 162253, Seoul

B9 5SS

Heartlands Hospital /ID# 163534, Birmingham

CF14 4EN

University Hospital of Wales /ID# 162726, Cardiff

HA1 3UJ

Northwick Park Hospital /ID# 162727, Harrow

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INDUSTRY