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)

Completed · Phase 3

Conditions studied: Graft-versus-host Disease (GVHD)

In brief

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).

Key facts

Study ID

NCT03112603

Run by

Incyte Corporation

People needed

330

Starts

2017-06-29

Expected to finish

2022-12-15

Last updated by the study team

2025-08-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Incyte Investigative Site — Duarte, California, United States
• Incyte Investigative Site — La Jolla, California, United States
• Incyte Investigative Site — Los Angeles, California, United States
• Incyte Investigative Site — New Haven, Connecticut, United States
• Incyte Investigative Site — Wilmington, Delaware, United States
• Incyte Investigative Site — Gainesville, Florida, United States
• Incyte Investigative Site — Tampa, Florida, United States
• Incyte Investigative Site — Chicago, Illinois, United States
• Incyte Investigative Site — Chicago, Illinois, United States
• Incyte Investigative Site — Chicago, Illinois, United States
• Incyte Investigative Site — Maywood, Illinois, United States
• Incyte Investigative Site — Indianapolis, Indiana, United States
• Incyte Investigative Site — Westwood, Kansas, United States
• Incyte Investigative Site — Lexington, Kentucky, United States
• Incyte Investigative Site — Boston, Massachusetts, United States
• Incyte Investigative Site — Boston, Massachusetts, United States
• Incyte Investigative Site — Omaha, Nebraska, United States
• Incyte Investigative Site — Hackensack, New Jersey, United States
• Incyte Investigative Site — New York, New York, United States
• Incyte Investigative Site — New York, New York, United States
• Incyte Investigative Site — New York, New York, United States
• Incyte Investigative Site — Chapel Hill, North Carolina, United States
• Incyte Investigative Site — Durham, North Carolina, United States
• Incyte Investigative Site — Winston-Salem, North Carolina, United States
• Incyte Investigative Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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