Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

PHASE3TerminatedINTERVENTIONAL
Enrollment

405

Participants

Timeline

Start Date

January 3, 2014

Primary Completion Date

December 29, 2015

Study Completion Date

March 14, 2017

Conditions
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Interventions
DRUG

Blinatumomab

Blinatumomab is administered as a continuous intravenous infusion (CIV).

DRUG

Standard of Care Chemotherapy

"* FLAG (fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor) ± anthracycline-based regimen (e.g. idarubicin 10 mg/m² days 1 \& 3; fludarabine 30 mg/m² days 1-5; cytarabine arabinoside 2 g/m² days 1-5). Patients \> 60 years: Idarubicin 5 mg/m² day 1 \& 3; fludarabine 20 mg/m² day 1-5; cytarabine arabinoside 1 g/m² day 1-5~* HiDAC (high-dose cytarabine arabinoside) - based regimen ≥1 g/m²/day ± anthracycline and/or in combination with other drugs such as native Escherichia coli asparaginase, polyethylene glycol linked to asparaginase (PEG-asparaginase), vinca alkaloids, steroids, etoposide or alkylating agents~* High-dose methotrexate-based regimen (HDMTX; 500 mg/m² to 3 g/m² infused up to 24 hours) in combination with native E. coli asparaginase, PEG-asparaginase, vinca alkaloids, steroids, etoposide or alkylating agents.~* Clofarabine as a single agent as recommended in the prescribing information or clofarabine-based regimens with 20 mg/m²/day for up to 5 days."

Trial Locations (117)

8

Research Site, Dublin

1090

Research Site, Vienna

1140

Research Site, Vienna

1200

Research Site, Brussels

1756

Research Site, Sofia

2060

Research Site, Antwerp

2065

Research Site, St Leonards

3000

Research Site, Leuven

3050

Research Site, Parkville

3181

Research Site, Prahran

4000

Research Site, Plovdiv

4029

Research Site, Herston

4600

Research Site, Wels

5000

Research Site, Adelaide

5020

Research Site, Salzburg

5530

Research Site, Yvoir

6150

Research Site, Murdoch

8000

Research Site, Bruges

9000

Research Site, Ghent

10002

Research Site, Taipei

10065

Research Site, New York

10126

Research Site, Torino

10676

Research Site, Athens

11527

Research Site, Athens

12200

Research Site, Berlin

21201

Research Site, Baltimore

24116

Research Site, Kiel

24127

Research Site, Bergamo

26500

Research Site, Pátrai

27710

Research Site, Durham

28041

Research Site, Madrid

28100

Research Site, Novara

29607

Research Site, Greenville

30174

Research Site, Venezia

30322

Research Site, Atlanta

31059

Research Site, Toulouse

31096

Research Site, Haifa

33011

Research Site, Oviedo

33604

Research Site, Pessac

34093

Research Site, Istanbul

35340

Research Site, Izmir

37007

Research Site, Salamanca

37134

Research Site, Verona

37232

Research Site, Nashville

40138

Research Site, Bologna

40447

Research Site, Taichung

44093

Research Site, Nantes

45110

Research Site, Ioannina

45147

Research Site, Essen

46026

Research Site, Valencia

48149

Research Site, Münster

49100

Research Site, Petah Tikva

50006

Research Site, Changhua

50134

Research Site, Florence

50937

Research Site, Cologne

52621

Research Site, Tel Litwinsky

53226

Research Site, Milwaukee

55905

Research Site, Rochester

57010

Research Site, Thessaloniki

60590

Research Site, Frankfurt am Main

60637

Research Site, Chicago

63110

Research Site, St Louis

64239

Research Site, Tel Aviv

64460

Research Site, Monterrey

69120

Research Site, Heidelberg

69495

Research Site, Pierre-Bénite

70124

Research Site, Bari

70403

Research Site, Tainan City

72076

Research Site, Tübingen

75475

Research Site, Paris

77030

Research Site, Houston

78157

Research Site, Le Chesnay

79106

Research Site, Freiburg im Breisgau

80131

Research Site, Napoli

81377

Research Site, München

89081

Research Site, Ulm

90095

Research Site, Los Angeles

90146

Research Site, Palermo

91010

Research Site, Duarte

91031

Research Site, Jerusalem

91120

Research Site, Jerusalem

94010

Research Site, Créteil

94143

Research Site, San Francisco

97080

Research Site, Würzburg

125167

Research Site, Moscow

185019

Research Site, Petrozavodsk

410012

Research Site, Saratov

603126

Research Site, Nizhny Novgorod

02111

Research Site, Boston

02215

Research Site, Boston

M5G 2M9

Research Site, Toronto

H1T 2M4

Research Site, Montreal

625 00

Research Site, Brno

500 05

Research Site, Hradec Králové

100 34

Research Site, Prague

128 20

Research Site, Prague

04103

Research Site, Leipzig

00133

Research Site, Roma

00161

Research Site, Roma

07760

Research Site, Mexico City

20-081

Research Site, Lublin

02-776

Research Site, Warsaw

04-141

Research Site, Warsaw

50-367

Research Site, Wroclaw

614-735

Research Site, Busan

110-744

Research Site, Seoul

135-710

Research Site, Seoul

138-736

Research Site, Seoul

08916

Research Site, Badalona

01330

Research Site, Adana

06100

Research Site, Ankara

BS2 8ED

Research Site, Bristol

NW3 2PF

Research Site, London

OX3 7LJ

Research Site, Oxford

S10 2JF

Research Site, Sheffield

SO16 6YD

Research Site, Southampton

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY