Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

March 10, 2017

Primary Completion Date

June 24, 2019

Study Completion Date

April 23, 2021

Conditions
Corticosteroid Refractory Acute Graft vs Host Disease
Interventions
DRUG

Ruxolitinib (RUX)

Ruxolitinib was provided as 5 mg tablets for oral use.

DRUG

Best Available Therapy (BAT)

BAT was based on the investigator's best judgment, taking into account the manufacturer's instructions, labeling, patient's medical condition, and institutional guidelines for any dose adjustment. The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mesenchymal stromal cells (MSC), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, or infliximab. No other types or combinations of BAT were permitted.

Trial Locations (103)

1797

Novartis Investigative Site, Sofia

2145

Novartis Investigative Site, Westmead

3002

Novartis Investigative Site, Parkville

4029

Novartis Investigative Site, Herston

6150

Novartis Investigative Site, Murdoch

8036

Novartis Investigative Site, Graz

10126

Novartis Investigative Site, Torino

11211

Novartis Investigative Site, Riyadh

13125

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

16147

Novartis Investigative Site, Genova

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

25123

Novartis Investigative Site, Brescia

28009

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

29009

Novartis Investigative Site, Málaga

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33006

Novartis Investigative Site, Oviedo

33100

Novartis Investigative Site, Udine

33604

Novartis Investigative Site, Pessac

36212

Novartis Investigative Site, Vigo

38043

Novartis Investigative Site, Grenoble

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

40447

Novartis Investigative Site, Taichung

41013

Novartis Investigative Site, Seville

41400

Novartis Investigative Site, Istanbul

42270

Novartis Investigative Site, Saint Priest En Jarez

45147

Novartis Investigative Site, Essen

46026

Novartis Investigative Site, Valencia

48149

Novartis Investigative Site, Münster

49033

Novartis Investigative Site, Angers

50134

Novartis Investigative Site, Florence

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55131

Novartis Investigative Site, Mainz

59000

Novartis Investigative Site, Lille

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

68305

Novartis Investigative Site, Mannheim

69495

Novartis Investigative Site, Pierre-Bénite

71013

Novartis Investigative Site, San Giovanni Rotondo

72076

Novartis Investigative Site, Tübingen

75012

Novartis Investigative Site, Paris

75013

Novartis Investigative Site, Paris

75019

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

79106

Novartis Investigative Site, Freiburg im Breisgau

86179

Novartis Investigative Site, Augsburg

87042

Novartis Investigative Site, Limoges

89081

Novartis Investigative Site, Ulm

125167

Novartis Investigative Site, Moscow

3109601

Novartis Investigative Site, Haifa

4941492

Novartis Investigative Site, Petah Tikva

6423906

Novartis Investigative Site, Tel Aviv

9112001

Novartis Investigative Site, Jerusalem

A-4010

Novartis Investigative Site, Linz

T2N 4N2

Novartis Investigative Site, Calgary

V5Z 1M9

Novartis Investigative Site, Vancouver

L8V 5C2

Novartis Investigative Site, Hamilton

K1H 8L6

Novartis Investigative Site, Ottawa

M5G 2M9

Novartis Investigative Site, Toronto

H1T 2M4

Novartis Investigative Site, Montreal

H4A 3J1

Novartis Investigative Site, Montreal

S7N 4H4

Novartis Investigative Site, Saskatoon

128 20

Novartis Investigative Site, Prague

DK-2100

Novartis Investigative Site, Copenhagen

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

570 10

Novartis Investigative Site, Thessaloniki

Unknown

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Izmir

00168

Novartis Investigative Site, Roma

453-8511

Novartis Investigative Site, Nagoya

812-8582

Novartis Investigative Site, Fukuoka

060 8648

Novartis Investigative Site, Sapporo

650-0047

Novartis Investigative Site, Kobe

663 8501

Novartis Investigative Site, Nishinomiya

259-1193

Novartis Investigative Site, Isehara

980 8574

Novartis Investigative Site, Sendai

700-8558

Novartis Investigative Site, Okayama

565 0871

Novartis Investigative Site, Suita

113-8677

Novartis Investigative Site, Bunkyo Ku

104 0045

Novartis Investigative Site, Chuo Ku

105-8470

Novartis Investigative Site, Minato Ku

160 8582

Novartis Investigative Site, Shinjuku-ku

545-8586

Novartis Investigative Site, Osaka

3508 GA

Novartis Investigative Site, Utrecht

0372

Novartis Investigative Site, Oslo

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

06100

Novartis Investigative Site, Ankara

06500

Novartis Investigative Site, Ankara

SE5 9RS

Novartis Investigative Site, London

WC1E 6HX

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY