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)
A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)
3 other identifiers
interventional
330
30 countries
187
Brief Summary
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2017
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2020
CompletedResults Posted
Study results publicly available
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedAugust 12, 2025
August 1, 2025
2.9 years
April 4, 2017
December 10, 2021
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit
ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.
Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
Secondary Outcomes (23)
Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
Rate of Failure-free Survival (FFS)
Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
Rate of FFS at Study Completion
From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)
Best Overall Response (BOR) at Cycle 7 Day 1
up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
BOR During Cross-over Treatment With Ruxolitinib
from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
- +18 more secondary outcomes
Study Arms (2)
Ruxolitinib
EXPERIMENTALRuxolitinib for the treatment period and extension period.
Best Available Therapy
ACTIVE COMPARATORBest available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.
Interventions
Ruxolitinib twice daily at the protocol-defined starting dose.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) \> 1000/mm\^3 and platelet count \> 25,000/ mm\^3
- Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization:
- Moderate cGvHD: At least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1
- Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3
- Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of \< 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
- A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week, OR
- Disease persistence without improvement despite continued treatment with prednisone at \> 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks, OR
- Increase to prednisolone dose to \> 0.25 mg/kg/day after 2 unsuccessful attempts to taper the dose
- Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib
You may not qualify if:
- Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
- Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment
- \* Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.
- Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1
- Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
- Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
- Steroid refractory cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for preemptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible
- Any corticosteroid therapy for indications other than cGvHD at doses \> 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (191)
Incyte Investigative Site
Tucson, Arizona, 85724, United States
Incyte Investigative Site
Duarte, California, 31010, United States
Incyte Investigative Site
La Jolla, California, 92093-0987, United States
Incyte Investigative Site
Los Angeles, California, 90033, United States
Incyte Investigative Site
New Haven, Connecticut, 06510, United States
Incyte Investigative Site
Wilmington, Delaware, 19803, United States
Incyte Investigative Site
Gainesville, Florida, 32610, United States
Incyte Investigative Site
Tampa, Florida, 33612, United States
Incyte Investigative Site
Chicago, Illinois, 60611, United States
Incyte Investigative Site
Chicago, Illinois, 60612, United States
Incyte Investigative Site
Chicago, Illinois, 60637, United States
Incyte Investigative Site
Maywood, Illinois, 60153, United States
Incyte Investigative Site
Indianapolis, Indiana, 46237, United States
Incyte Investigative Site
Westwood, Kansas, 66205, United States
Incyte Investigative Site
Lexington, Kentucky, 40536, United States
Incyte Investigative Site
Boston, Massachusetts, 02114, United States
Incyte Investigative Site
Boston, Massachusetts, 02215, United States
Incyte Investigative Site
Omaha, Nebraska, 68198-7680, United States
Incyte Investigative Site
Hackensack, New Jersey, 07601, United States
Incyte Investigative Site
New York, New York, 10021, United States
Incyte Investigative Site
New York, New York, 10032, United States
Incyte Investigative Site
New York, New York, 11040, United States
Incyte Investigative Site
Chapel Hill, North Carolina, 27599, United States
Incyte Investigative Site
Durham, North Carolina, 27710, United States
Incyte Investigative Site
Winston-Salem, North Carolina, 27157, United States
Incyte Investigative Site
Cincinnati, Ohio, 45242, United States
Incyte Investigative Site
Cleveland, Ohio, 44106-5048, United States
Incyte Investigative Site
Cleveland, Ohio, 44195, United States
Incyte Investigative Site
Columbus, Ohio, 43210, United States
Incyte Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Incyte Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Incyte Investigative Site
Pittsburgh, Pennsylvania, 15224, United States
Incyte Investigative Site
Pittsburgh, Pennsylvania, 15232, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98109, United States
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Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
Darlinghurst, New South Wales, 2010, Australia
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Parkville, Victoria, 3002, Australia
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Innsbruck, Tyrol, 6020, Austria
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Graz, 8036, Austria
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Linz, A-4010, Austria
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Vienna, A-1090, Austria
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Antwerp, 2060, Belgium
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Vancouver, British Columbia, V5Z 1M9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Prague, Czech Republic, 128 20, Czechia
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Hradec Králové, CZE, 500 05, Czechia
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Prague, 150 06, Czechia
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Copenhagen, DK-2100, Denmark
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Odense, DK 5000, Denmark
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Bordeaux, Aquitaine, 33076, France
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Amiens Cedex1, 80054, France
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Caen, 14033, France
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Lille, 59037, France
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Limoges, 87042, France
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Lyon, 69373, France
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Montpellier, 34295, France
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Paris, 75475, France
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Paris, 75571, France
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Paris, 75935, France
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Pierre-Benite Cédex, 69495, France
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Rennes, 35033, France
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Rouen, 76038, France
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Saint-Priest-en-Jarez, 42271, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Mannheim, Baden-Wurttemberg, 68167, Germany
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Augsburg, 86156, Germany
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Berlin, 13125, Germany
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Cologne, 50937, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20099, Germany
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Hamburg, 20246, Germany
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Jena, 07747, Germany
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Kiel, 24105, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Münster, 48149, Germany
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Ulm, Germany
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Würzburg, 97080, Germany
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Athens, GR, Greece
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Pátrai, GR, 265 00, Greece
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Thessaloniki, GR, Greece
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Athens, Greece
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Budapest, 1097, Hungary
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Navi Mumbai, Maharashtra, 410210, India
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Pune, Maharashtra, 411004, India
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Delhi, 110 085, India
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Vellore, 632004, India
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 64239, Israel
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Ancona, AN, 60126, Italy
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Bergamo, BG, 24127, Italy
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Bologna, BO, 40138, Italy
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Brescia, BS, 25123, Italy
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Genova, GE, 16132, Italy
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Genova, GE, 16147, Italy
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Milan, MI, 20132, Italy
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Milan, MI, 20133, Italy
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Rozzano, MI, 20089, Italy
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Palermo, PA, 90146, Italy
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Pescara, PE, 65124, Italy
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Parma, PR, 43100, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00133, Italy
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Roma, RM, 00165, Italy
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Roma, RM, 00168, Italy
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Torino, TO, 10126, Italy
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Udine, UD, 33100, Italy
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Perugia, 06132, Italy
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Nagoya, Aichi-ken, 453-8511, Japan
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Fukuoka, Fukuoka, 812-8582, Japan
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Sapporo, Hokkaido, 060-8648, Japan
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Kobe, Hyōgo, 650-0047, Japan
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Nishinomiya, Hyōgo, 663 8501, Japan
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Isehara, Kanagawa, 259-1193, Japan
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Sendai, Miyagi, 980-8574, Japan
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Osaka, Osaka, 545-8586, Japan
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Suita, Osaka, 565-0871, Japan
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Shimotsuke, Tochigi, 329-0498, Japan
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Bunkyō-ku, Tokyo, 113-8677, Japan
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Minato-ku, Tokyo, 105-8470, Japan
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Shinjuku-ku, Tokyo, 160-8582, Japan
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Kyoto, 606-8507, Japan
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Okayama, 700-8558, Japan
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Amman, 11941, Jordan
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Utrecht, The Netherlands, 3508 GA, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Oslo, 0424, Norway
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Wroclaw, Lower Silesian Voivodeship, Poland
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Gliwice, Silesian Voivodeship, Poland
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Katowice, Poland
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Krakow, Poland
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Warsaw, Poland
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Lisbon, Portugal
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Porto, Portugal
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Ponce, 11040, Puerto Rico
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Bucharest, 022328, Romania
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Bucharest, Romania
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Moscow, 125167, Russia
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Saint Petersburg, 197022, Russia
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Riyadh, 11211, Saudi Arabia
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Córdoba, Andalusia, 14004, Spain
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Seville, Andalusia, 41013, Spain
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Donostia / San Sebastian, Basque Country, 20080, Spain
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Salamanca, Castille and León, 37007, Spain
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Barcelona, Catalonia, 08026, Spain
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Barcelona, Catalonia, 08035, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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El Palmar, Murica, Spain
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Valencia, Valencia, 46010, Spain
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Barcelona, 08026, Spain
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Las Palmas de Gran Canaria, 35012, Spain
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Madrid, 28006, Spain
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Madrid, 28041, Spain
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Gothenburg, SE-413 45, Sweden
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Uppsala, SE-751 85, Sweden
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Basel, 4031, Switzerland
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Zurich, 8091, Switzerland
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06460, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Glasgow, G51 4TF, United Kingdom
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London, NW1 2PQ, United Kingdom
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London, SE5 9RS, United Kingdom
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Manchester, M13 9WL, United Kingdom
Related Publications (5)
Zeiser R, Russo D, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hamad N, Burock K, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F. Ruxolitinib in Patients With Corticosteroid-Refractory or Corticosteroid-Dependent Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of the Phase III REACH3 Study. J Clin Oncol. 2025 Aug 10;43(23):2566-2571. doi: 10.1200/JCO-24-02477. Epub 2025 Jun 25.
PMID: 40561385DERIVEDMahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212.
PMID: 40472328DERIVEDLe RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.
PMID: 35363318DERIVEDZeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.
PMID: 34260836DERIVEDJagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.
PMID: 29316837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Incyte Corporation
- Organization
- Call Center
Study Officials
- STUDY DIRECTOR
Rodica Morariu-Zamfir
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 13, 2017
Study Start
June 29, 2017
Primary Completion
May 8, 2020
Study Completion
December 15, 2022
Last Updated
August 12, 2025
Results First Posted
April 15, 2022
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share