Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

November 2, 2021

Primary Completion Date

June 24, 2027

Study Completion Date

September 30, 2031

Conditions
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Interventions
DRUG

Blinatumomab

Continuous intravenous (cIV) infusion

DRUG

Low-intensity chemotherapy regimen

Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

DRUG

SOC chemotherapy regimen

Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Trial Locations (185)

1070

RECRUITING

Institut Jules Bordet, Anderlecht

1088

RECRUITING

Semmelweis Egyetem, Budapest

1097

RECRUITING

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1140

RECRUITING

Hanusch Krankenhaus, Vienna

1200

TERMINATED

Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Brussels

1797

TERMINATED

Specialized Hospital for Active Treatment of Hematology Diseases EAD, Sofia

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2065

RECRUITING

Royal North Shore Hospital, St Leonards

2100

RECRUITING

Rigshospitalet, København Ø

2145

TERMINATED

Westmead Hospital, Westmead

2170

RECRUITING

Liverpool Hospital, Liverpool

2605

RECRUITING

Canberra Hospital, Garran

2650

RECRUITING

Universitair Ziekenhuis Antwerpen, Edegem

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3004

RECRUITING

The Alfred Hospital, Melbourne

3010

ACTIVE_NOT_RECRUITING

Inselspital Bern, Bern

3084

RECRUITING

Austin Health, Austin Hospital, Heidelberg

3168

TERMINATED

Monash Medical Centre, Clayton

3300

RECRUITING

Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger

3500

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

4000

RECRUITING

Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège

4020

RECRUITING

Ordensklinikum Linz Elisabethinen, Linz

4029

RECRUITING

Royal Brisbane and Womens Hospital, Herston

4032

RECRUITING

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

4400

RECRUITING

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz, Nyíregyháza

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

RECRUITING

Odense Universitetshospital, Odense

5530

RECRUITING

Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur, Yvoir

6020

RECRUITING

Medizinische Universitaet Innsbruck, Innsbruck

6150

RECRUITING

Fiona Stanley Hospital, Murdoch

8000

RECRUITING

AZ Sint-Jan Brugge-Oostende AV, Bruges

8036

RECRUITING

Medizinische Universitaet Graz, Graz

8200

RECRUITING

Aarhus Universitetshospital, Aarhus N

8800

RECRUITING

AZ Delta Campus Rumbeke, Roeselare

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

RECRUITING

Aalborg Universitetshospital, Aalborg

10002

RECRUITING

National Taiwan University Hospital, Taipei

10676

RECRUITING

Evangelismos Hospital, Athens

11527

RECRUITING

Laiko General Hospital of Athens, Athens

12203

COMPLETED

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin

12462

RECRUITING

Attiko General University Hospital, Athens

13009

RECRUITING

Institut Paoli Calmettes, Marseille

14004

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

14080

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

16132

RECRUITING

Ospedale Policlinico San Martino IRCCS, Genova

20122

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20521

RECRUITING

Turku University Hospital, Turku

21000

RECRUITING

Centre Hospitalier Universitaire de Dijon - Hopital du Bocage, Dijon

24105

COMPLETED

Universitaetsklinikum Schleswig-Holstein - Kiel, Kiel

24127

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii, Bergamo

26504

RECRUITING

University Hospital of Patras, Pátrai

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

29607

COMPLETED

Saint Francis Hospital, Inc, Greenville

30174

RECRUITING

Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo, Mestre (VE)

31059

RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole, Toulouse

32804

RECRUITING

Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando, Orlando

33305

RECRUITING

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan District

33604

RECRUITING

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque, Pessac

34214

RECRUITING

Bagcilar Medipol Mega Universite Hastanesi, Istanbul

35000

RECRUITING

Centre Hospitalier Universitaire de Rennes, Rennes

35015

RECRUITING

Chungnam National University Hospital, Daejeon

35340

RECRUITING

Dokuz Eylul Universitesi Tip Fakultesi Hastanesi, Izmir

37007

RECRUITING

Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca, Salamanca

37134

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma, Verona

39008

RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

40002

RECRUITING

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

40138

RECRUITING

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola, Bologna

40225

COMPLETED

Universitaetsklinikum Duesseldorf, Düsseldorf

40458

RECRUITING

China Medical University Hospital, Taichung

40705

RECRUITING

Taichung Veterans General Hospital, Taichung

41013

TERMINATED

Hospital Universitario Virgen del Rocio, Seville

41110

RECRUITING

University Hospital of Larissa, Larissa

44000

RECRUITING

Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu, Nantes

44195

TERMINATED

Cleveland Clinic Foundation, Cleveland

45500

RECRUITING

University Hospital of Ioannina, Ioannina

46026

RECRUITING

Hospital Universitari i Politecnic La Fe, Valencia

49201

RECRUITING

Dong-A University Hospital, Busan

49241

RECRUITING

Pusan National University Hospital, Busan

51014

RECRUITING

Tartu University Hospital, Tartu

52787

RECRUITING

Hematologica Alta Especialidad, Huixquilucan

54511

RECRUITING

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy

55139

RECRUITING

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

57010

RECRUITING

General Hospital of Thessaloniki Georgios Papanikolaou, Thessaloniki

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

59000

RECRUITING

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez, Lille

64460

RECRUITING

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey

65124

RECRUITING

Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito, Pescara

69120

COMPLETED

Universitaetsklinikum Heidelberg, Heidelberg

69645

RECRUITING

Hopital Lyon Sud, Pierre-Bénite

70124

RECRUITING

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari

70403

RECRUITING

National Cheng Kung University Hospital, Tainan City

71500

RECRUITING

University Hospital of Heraklion, Heraklion

73100

RECRUITING

Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II, Lecce

75010

RECRUITING

Hopital Saint Louis, Paris

75012

RECRUITING

Hopital Saint Antoine, Paris

77030

COMPLETED

University of Texas MD Anderson Cancer Center, Houston

78157

RECRUITING

Centre Hospitalier de Versailles - Hopital Andre Mignot, Le Chesnay

80131

RECRUITING

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli

81377

COMPLETED

Klinikum der LMU Muenchen, München

86156

COMPLETED

Universitaetsklinikum Augsburg, Augsburg

91010

RECRUITING

City of Hope National Medical Center, Duarte

94010

RECRUITING

Hopital Henri Mondor, Créteil

94143

RECRUITING

University of California San Francisco, San Francisco

400015

RECRUITING

Institutul Oncologic Prof Dr Ion Chiricuta, Cluj-Napoca

550245

RECRUITING

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu

700483

RECRUITING

Institutul Regional de Oncologie Iasi, Iași

7500921

RECRUITING

Fundacion Arturo Lopez Perez, Santiago

7580206

RECRUITING

Inmunocel, Santiago

7650729

RECRUITING

Clinica Alemana de Santiago, Santiago

92868-3201

RECRUITING

University of California Irvine, Orange

70335-902

RECRUITING

Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal, Brasília

74605-020

RECRUITING

Hospital das Clinicas da Universidade Federal de Goias, Goiânia

90035-003

RECRUITING

Hospital das Clinicas de Porto Alegre, Porto Alegre

17210-120

RECRUITING

Fundacao Amaral Carvalho, Jaú

14048-900

RECRUITING

Hosp Clin Fac Med Ribeirao Preto Usp, Ribeirão Preto

15090-000

RECRUITING

Hospital de Base de Sao Jose do Rio Preto, São Jose Do Rio Preto

22640-000

RECRUITING

Hemorio, Rio de Janeiro

01246-000

RECRUITING

Instituto Cancer Sao Paulo Icesp, São Paulo

T2N 5G2

RECRUITING

Arthur J E Child Comprehensive Cancer Centre, Calgary

V5Z 1M9

RECRUITING

Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre, Vancouver

R3H 0V9

RECRUITING

Cancer Care Manitoba, Winnipeg

B3H 1V8

RECRUITING

Queen Elizabeth II, Health Sciences Centre, Halifax

L8V 5C2

RECRUITING

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre, Hamilton

K1H 8L6

RECRUITING

The Ottawa Hospital Cancer Centre, Ottawa

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre, Toronto

H1T 2M4

RECRUITING

CEMTL Hopital Maisonneuve Rosemont, Montreal

625 00

RECRUITING

Fakultni nemocnice Brno, Brno

500 05

RECRUITING

Fakultni nemocnice Hradec Kralove, Hradec Králové

128 20

RECRUITING

Ustav hematologie a krevni transfuze, Prague

13 419

RECRUITING

North Estonia Medical Centre, Tallinn

00029

RECRUITING

Helsinki University Hospital, Helsinki

06202

RECRUITING

Centre Hospitalier Universitaire Archet 2, Nice

01307

COMPLETED

Universitaetsklinikum Dresden, Dresden

07747

COMPLETED

Universitaetsklinikum Jena, Jena

Unknown

RECRUITING

Queen Mary Hospital, The University of Hong Kong, Hong Kong

RECRUITING

Princess Margaret Hospital, Kowloon

RECRUITING

Tuen Mun Hospital, New Territories

06156

RECRUITING

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia, Perugia

00161

RECRUITING

Azienda Ospedaliera Policlinico Umberto I, Roma

466-8560

RECRUITING

Nagoya University Hospital, Nagoya

010-8543

RECRUITING

Akita University Hospital, Akita

296-8602

RECRUITING

Tesshokai Kameda General Hospital, Kamogawa-shi

910-1193

RECRUITING

University of Fukui Hospital, Yoshida-gun

812-8582

RECRUITING

Kyushu University Hospital, Fukuoka

830-0011

RECRUITING

Kurume University Hospital, Kurume-shi

960-1295

RECRUITING

Fukushima Medical University Hospital, Fukushima

371-0821

RECRUITING

Gunma Saiseikai Maebashi Hospital, Maebashi

003-0006

RECRUITING

Sapporo Hokuyu Hospital, Sapporo

650-0047

RECRUITING

Kobe City Medical Center General Hospital, Kobe

920-8641

RECRUITING

Kanazawa University Hospital, Kanazawa

259-1193

RECRUITING

Tokai University Hospital, Isehara-shi

232-0024

RECRUITING

Yokohama City University Medical Center, Yokohama

606-8507

RECRUITING

Kyoto University Hospital, Kyoto

980-8574

RECRUITING

Tohoku University Hospital, Sendai

852-8501

RECRUITING

Nagasaki University Hospital, Nagasaki

701-1192

RECRUITING

National Hospital Organization Okayama Medical Center, Okayama

545-8586

RECRUITING

Osaka Metropolitan University Hospital, Osaka

589-8511

RECRUITING

Kindai University Hospital, Osakasayama-shi

329-0498

RECRUITING

Jichi Medical University Hospital, Shimotsuke-shi

113-8677

RECRUITING

Tokyo Metropolitan Komagome Hospital, Bunkyo-ku

173-8610

RECRUITING

Nihon University Itabashi Hospital, Itabashi-ku

990-9585

RECRUITING

Yamagata University Hospital, Yamagata

01330

RECRUITING

Centro Oncologico Internacional, Mexico City

9713 GZ

ACTIVE_NOT_RECRUITING

Universitair Medisch Centrum Groningen, Groningen

3004-561

RECRUITING

Unidade Local de Saude de Coimbra, EPE, Coimbra

1099-023

RECRUITING

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

1169-050

RECRUITING

Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos, Lisbon

1649-035

RECRUITING

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria, Lisbon

4200-072

RECRUITING

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto

022328

RECRUITING

Institutul Clinic Fundeni, Bucharest

833 10

RECRUITING

Narodny onkologicky ustav, Bratislava

851 07

RECRUITING

Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda, Bratislava

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital Yonsei University Health System, Seoul

06591

RECRUITING

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08916

RECRUITING

Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol, Badalona

08035

RECRUITING

Hospital Universitari Vall d Hebron, Barcelona

08908

RECRUITING

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals, L'Hospitalet de Llobregat

413 45

RECRUITING

Sahlgrenska Universitetssjukhuset, Gothenburg

06100

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara

06800

RECRUITING

Ankara Bilkent Sehir Hastanesi, Ankara

07025

RECRUITING

Memorial Antalya Hastanesi, Antalya

NW1 2PG

RECRUITING

University College London, London

SE5 9RS

RECRUITING

Kings College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT04994717 - Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter