CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 310 enrolled
Drug / intervention
Ruxolitinib (RUX) +1 moredrug
Likely dose
Ruxolitinib (RUX) 5 mgfrom 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/NCT02913261
NCT02913261Phase 3Completed
CompareCT.gov

A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

Novartis Pharmaceuticals·interventional·Posted Sep 23, 2016·Updated Feb 8, 2023

In Brief

A Phase 3 clinical trial evaluating Ruxolitinib (RUX) and Best Available Therapy (BAT) for Corticosteroid Refractory Acute Graft vs Host Disease. Completed, enrolled 310 participants across 103 sites in 22 countries.

Detailed Summary

Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorticosteroid Refractory Acute Graft vs Host Disease
CountriesAustralia, Austria, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, Norway, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 23, 2016
Enrollment StartMar 10, 2017
Primary CompletionJun 24, 2019
Study CompletionApr 23, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.8 years ago

Interventions

Ruxolitinib (RUX)drug

Ruxolitinib was provided as 5 mg tablets for oral use.

Best Available Therapy (BAT)drug

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.