Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

PHASE3TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 24, 2021

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Nucleophosmin 1-mutated Acute Myeloid Leukemia
Interventions
DRUG

Entospletinib

400 mg, Orally as tablets

DRUG

Placebo

Orally as tablets

DRUG

Cytarabine

Continuous infusion

DRUG

Anthracycline

Either daunorubicin or idarubicin was administered via slow intravenous (IV) push

Trial Locations (83)

1083

Semmelweis Egyetem, Budapest

1097

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4400

Jósa András Oktatókórház, Nyíregyháza

6725

Szent-Györgyi Albert Klinikai Központ, Szeged

10003

Hospital San Pedro de Alcantara, Cáceres

10029

Mount Sinai Health System, New York

14000

Hôpital Côte De Nacre, Caen

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21565

Gachon University Gil Medical Center, Incheon

27710

Duke Cancer Institute, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28100

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara

29425

Hollings Cancer Center, Charleston

29607

Bon Secours St. Francis Cancer Center, Greenville

30625

Medizinische Hochschule Hannover, Hanover

33011

Hospital Universitario Central de Asturias, Oviedo

35015

Chungnam National University Hospital, Daejeon

38114

Städtisches Klinikum Braunschweig, Braunschweig

40138

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna

40479

Marien Hospital Düsseldorf, Düsseldorf

41944

Kyungpook National University Hospital, Daegu

42472

Daegu Catholic University Medical Center, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

46010

Hospital Clínico Universitario de Valencia, Valencia

46026

Hospital Universitari I Politecnic La Fe, Valencia

46237

Indiana Blood & Marrow Transplantation, Indianapolis

47166

Helios St. Johannes Klinik, Duisburg

48109

University of Michigan Medical School, Ann Arbor

48121

Ospedale Santa Maria delle Croci di Ravenna, Ravenna

48149

Universitätsklinikum Münster, Münster

48202

Henry Ford Health System, Detroit

49933

Centre Hosptitalier Universitaire d'Angers, Angers

59000

Hôpital Claude Huriez, Lille

62431

Tel Aviv Sourasky Medical Center, Tel Aviv

68167

Universitätsmedizin Mannheim, Mannheim

69310

Centre Hospitalier Lyon-Sud, Pierre-Bénite

69710

Assuta Hospital - Ramat HaHayal, Tel Aviv

70124

Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari, Bari

75012

Hôpital Saint-Antoine, Paris

75246

Baylor University Medical Center, Dallas

75475

Hôpital Saint-Louis, Paris

75743

Hôpital Necker-Enfants Malades, Paris

76038

Centre de Lutte Contre le Cancer - Centre Henri-Becquerel, Rouen

90095

UCLA - Jonsson Comprehensive Cancer Center, Los Angeles

91010

City of Hope, Duarte

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

3109601

Rambam Health Care Campus, Haifa

7030000

Shamir Medical Center (Assaf Harofeh), Be’er Ya‘aqov

7747629

Samson Assuta Ashdod University Hospital, Ashdod

9112001

Hadassah University Hospital Ein Kerem, Jerusalem

81520-060

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba

60430-372

Hospital Universitário Walter Cantídio, Fortaleza

17210-120

Hospital Amaral Carvalho, Jaú

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

90050-170

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre, Porto Alegre

20 580-120

Instituto Nacional de Câncer - Brazil, Rio de Janeiro

15090-000

Hospital de Base - São José do Rio Preto, Rio Preto

01321001

A Beneficência Portuguesa de São Paulo - Unidade Mirante, São Paulo

03102-002

Instituto Brasileiro de Controle do Câncer - São Camilo Oncologia - Unidade Mooca, São Paulo

L8V 5C2

Juravinski Hospital, Hamilton

S7N 4H4

Saskatchewan Cancer Agency, Saskatoon

M5G 1X6

Princess Margaret Cancer Centre, Toronto

625 00

Fakultni Nemocnice Brno, Brno

500 05

Fakultní Nemocnice Hradec Králové, Hradec Králové

100 34

Fakultní Nemocnice Královské Vinohrady, Prague

CS23079 - 06202

Hôpital l'Archet, Nice

80-214

Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdansk

71-252

Samodzielny Publiczny Szpital Kliniczny Nr im. Prof. Tadeusza Sokołowskiego, Szczecin

02-097

Uniwersyteckie Centrum Kliniczne WUM - Centralny Szpital Kliniczny, Warsaw

02-776

Instytut Hematologii I Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wroclaw

03080

Seoul National University Hospital, Incheon

03722

Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

Catholic University of Korea Seoul Saint Mary's Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

08916

Hospital Germans Trias i Pujol, Badalona

08036

Institut D'Investigacions Biomédiques August Pi I Sunyer, Barcelona

08908

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona

07198

Hospital Son Llàtzer, Palma de Mallorca

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kronos Bio

INDUSTRY