A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

June 29, 2017

Primary Completion Date

May 8, 2020

Study Completion Date

December 15, 2022

Conditions
Graft-versus-host Disease (GVHD)
Interventions
DRUG

Ruxolitinib

Ruxolitinib twice daily at the protocol-defined starting dose.

DRUG

Extracorporeal photopheresis (ECP)

Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study).

DRUG

Low-dose methotrexate (MTX)

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Mycophenolate mofetil (MMF)

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Infliximab

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Rituximab

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Pentostatin

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Imatinib

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

DRUG

Ibrutinib

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Trial Locations (191)

1097

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

1527

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

2010

Novartis Investigative Site, Darlinghurst

2060

Novartis Investigative Site, Antwerp

3000

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, Parkville

4000

Novartis Investigative Site, Liège

4031

Novartis Investigative Site, Basel

6020

Novartis Investigative Site, Innsbruck

8000

Novartis Investigative Site, Bruges

8036

Novartis Investigative Site, Graz

8091

Novartis Investigative Site, Zurich

9000

Novartis Investigative Site, Ghent

10021

Incyte Investigative Site, New York

10032

Incyte Investigative Site, New York

10126

Novartis Investigative Site, Torino

11040

Incyte Investigative Site, New York

Incyte Investigative Site, Ponce

11211

Novartis Investigative Site, Riyadh

11941

Novartis Investigative Site, Amman

13125

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

14033

Novartis Investigative Site, Caen

15224

Incyte Investigative Site, Pittsburgh

15232

Incyte Investigative Site, Pittsburgh

15706

Novartis Investigative Site, Santiago de Compostela

16132

Novartis Investigative Site, Genova

16147

Novartis Investigative Site, Genova

19104

Incyte Investigative Site, Philadelphia

19803

Incyte Investigative Site, Wilmington

20080

Novartis Investigative Site, Donostia / San Sebastian

20089

Novartis Investigative Site, Rozzano

20099

Novartis Investigative Site, Hamburg

20132

Novartis Investigative Site, Milan

20133

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

25123

Novartis Investigative Site, Brescia

27100

Novartis Investigative Site, Pavia

27157

Incyte Investigative Site, Winston-Salem

27599

Incyte Investigative Site, Chapel Hill

27710

Incyte Investigative Site, Durham

28006

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

31010

Incyte Investigative Site, Duarte

31059

Novartis Investigative Site, Toulouse

31096

Novartis Investigative Site, Haifa

32610

Incyte Investigative Site, Gainesville

33076

Novartis Investigative Site, Bordeaux

33100

Novartis Investigative Site, Udine

33612

Incyte Investigative Site, Tampa

34295

Novartis Investigative Site, Montpellier

35012

Novartis Investigative Site, Las Palmas de Gran Canaria

35033

Novartis Investigative Site, Rennes

37007

Novartis Investigative Site, Salamanca

37232

Incyte Investigative Site, Nashville

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

40536

Incyte Investigative Site, Lexington

41013

Novartis Investigative Site, Seville

42271

Novartis Investigative Site, Saint-Priest-en-Jarez

43100

Novartis Investigative Site, Parma

43210

Incyte Investigative Site, Columbus

44195

Incyte Investigative Site, Cleveland

45147

Novartis Investigative Site, Essen

45242

Incyte Investigative Site, Cincinnati

46010

Novartis Investigative Site, Valencia

46237

Incyte Investigative Site, Indianapolis

48149

Novartis Investigative Site, Münster

49100

Novartis Investigative Site, Petah Tikva

50937

Novartis Investigative Site, Cologne

53226

Incyte Investigative Site, Milwaukee

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55131

Novartis Investigative Site, Mainz

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

60153

Incyte Investigative Site, Maywood

60590

Novartis Investigative Site, Frankfurt

60611

Incyte Investigative Site, Chicago

60612

Incyte Investigative Site, Chicago

60637

Incyte Investigative Site, Chicago

64239

Novartis Investigative Site, Tel Aviv

65124

Novartis Investigative Site, Pescara

66205

Incyte Investigative Site, Westwood

67098

Novartis Investigative Site, Strasbourg

68167

Novartis Investigative Site, Mannheim

Novartis Investigative Site, Mannheim

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Benite Cédex

73104

Incyte Investigative Site, Oklahoma City

75390

Incyte Investigative Site, Dallas

75475

Novartis Investigative Site, Paris

75571

Novartis Investigative Site, Paris

75935

Novartis Investigative Site, Paris

76038

Novartis Investigative Site, Rouen

77030

Incyte Investigative Site, Houston

79106

Novartis Investigative Site, Freiburg im Breisgau

80054

Novartis Investigative Site, Amiens Cedex1

85724

Incyte Investigative Site, Tucson

86156

Novartis Investigative Site, Augsburg

87042

Novartis Investigative Site, Limoges

90033

Incyte Investigative Site, Los Angeles

90146

Novartis Investigative Site, Palermo

91054

Novartis Investigative Site, Erlangen

91120

Novartis Investigative Site, Jerusalem

97080

Novartis Investigative Site, Würzburg

98109

Incyte Investigative Site, Seattle

125167

Novartis Investigative Site, Moscow

197022

Novartis Investigative Site, Saint Petersburg

410210

Novartis Investigative Site, Navi Mumbai

411004

Novartis Investigative Site, Pune

632004

Novartis Investigative Site, Vellore

92093-0987

Incyte Investigative Site, La Jolla

06510

Incyte Investigative Site, New Haven

02114

Incyte Investigative Site, Boston

02215

Incyte Investigative Site, Boston

68198-7680

Incyte Investigative Site, Omaha

07601

Incyte Investigative Site, Hackensack

44106-5048

Incyte Investigative Site, Cleveland

A-4010

Novartis Investigative Site, Linz

A-1090

Novartis Investigative Site, Vienna

V5Z 1M9

Novartis Investigative Site, Vancouver

L8V 5C2

Novartis Investigative Site, Hamilton

K1H 8L6

Novartis Investigative Site, Ottawa

M5G 2M9

Novartis Investigative Site, Toronto

128 20

Novartis Investigative Site, Prague

500 05

Novartis Investigative Site, Hradec Králové

150 06

Novartis Investigative Site, Prague

DK-2100

Novartis Investigative Site, Copenhagen

DK 5000

Novartis Investigative Site, Odense

01307

Novartis Investigative Site, Dresden

07747

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

Unknown

Novartis Investigative Site, Ulm

Novartis Investigative Site, Athens

Novartis Investigative Site, Thessaloniki

Novartis Investigative Site, Athens

Novartis Investigative Site, Wroclaw

Novartis Investigative Site, Gliwice

Novartis Investigative Site, Katowice

Novartis Investigative Site, Krakow

Novartis Investigative Site, Warsaw

Novartis Investigational Site, Lisbon

Novartis Investigative Site, Porto

Novartis Investigational Site, Bucharest

Novartis Investigative Site, El Palmar

265 00

Novartis Investigative Site, Pátrai

110 085

Novartis Investigative Site, Delhi

00133

Novartis Investigative Site, Roma

00165

Novartis Investigative Site, Roma

00168

Novartis Investigative Site, Roma

06132

Novartis Investigative Site, Perugia

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

545-8586

Novartis Investigative Site, Osaka

565-0871

Novartis Investigative Site, Suita

329-0498

Novartis Investigative Site, Shimotsuke

113-8677

Novartis Investigative Site, Bunkyō-ku

105-8470

Novartis Investigative Site, Minato-ku

160-8582

Novartis Investigative Site, Shinjuku-ku

606-8507

Novartis Investigative Site, Kyoto

700-8558

Novartis Investigative Site, Okayama

3508 GA

Novartis Investigative Site, Utrecht

2333 ZA

Novartis Investigative Site, Leiden

6525 GA

Novartis Investigative Site, Nijmegen

3015 CE

Novartis Investigative Site, Rotterdam

0424

Novartis Investigative Site, Oslo

022328

Novartis Investigational Site, Bucharest

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08026

Novartis Investigative Site, Barcelona

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

SE-413 45

Novartis Investigative Site, Gothenburg

SE-751 85

Novartis Investigative Site, Uppsala

06100

Novartis Investigative Site, Ankara

06460

Novartis Investigative Site, Ankara

07100

Novartis Investigative Site, Antalya

G51 4TF

Novartis Investigative Site, Glasgow

NW1 2PQ

Novartis Investigative Site, London

SE5 9RS

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY