CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
Ruxolitinib +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03112603
NCT03112603Phase 3Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Apr 13, 2017·Updated Aug 12, 2025

In Brief

A Phase 3 clinical trial evaluating Ruxolitinib, Extracorporeal photopheresis (ECP), and 8 other interventions for Graft-versus-host Disease (GVHD). Completed, enrolled 330 participants across 191 sites in 31 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft-versus-host Disease (GVHD)
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartJun 29, 2017
Primary CompletionMay 8, 2020
Study CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.2 years ago

Interventions

Ruxolitinibdrug

Ruxolitinib twice daily at the protocol-defined starting dose.

Extracorporeal photopheresis (ECP)drug

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).

Low-dose methotrexate (MTX)drug

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.

Mycophenolate mofetil (MMF)drug

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.

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

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.

Infliximabdrug

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.

Rituximabdrug

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.

Pentostatindrug

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.

Imatinibdrug

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.

Ibrutinibdrug

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.