12 and older, any sex, with Graft-versus-host Disease (GVHD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) at Day 28Primary· From baseline to Day 28
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Responders - CR
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
19
Responders - VGPR
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
7
Responders - PR
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
13
Overall Response Rate (ORR)Secondary· From baseline to days 14, 56, and 100
Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
Day 14
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
62.0
49.7 – 73.2
Day 56
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
36.6
25.5 – 48.9
Day 100
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
32.4
21.8 – 44.5
Nonrelapse Mortality (NRM)Secondary· From baseline to Months 6, 9, 12, and 24
Defined as the proportion of subjects who died due to causes other than malignancy relapse.
6 months
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
44.4
32.5 – 55.7
9 months
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
48.2
35.8 – 59.5
12 months
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
52.9
39.6 – 64.5
24 months
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
64.8
46.0 – 78.5
Percentage of Participants With Six-month Duration of Response (DOR)Secondary· From Baseline up to 6 months
Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit.
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
68.2
49.6 – 81.2
Percentage of Participants With Three-month DORSecondary· From Baseline up to 3 months
Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit.
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
84.5
68.7 – 92.7
Relapse RateSecondary· From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Defined as the percentage of participants whose underlying malignancy relapsed.
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
7.0
2.3 – 15.7
Relapse-related Mortality RateSecondary· From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
5.6
1.6 – 13.8
Failure-free Survival (FFS)Secondary· From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
85.0
42.0 – 158.0
Overall Survival (OS)Secondary· From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
232.0
93.0 – 675.0
Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEsSecondary· From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE
TEAEs
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
71
Serious TEAEs
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
59
Grade 3 or Higher TEAEs
Group
Value
95% CI
Ruxolitinib in Combination With Corticosteroids
69
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ruxolitinib in Combination With Corticosteroids
Serious: 59/71 (83%)
Deaths: 46/71
Serious adverse events (101 terms)
Reaction
System
Ruxolitinib in Combination…
Sepsis
Infections and infestations
—
Pyrexia
General disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Lung infection
Infections and infestations
—
Pneumonia
Infections and infestations
—
Pneumatosis intestinalis
Gastrointestinal disorders
—
Bacteraemia
Infections and infestations
—
Acute kidney injury
Renal and urinary disorders
—
Diarrhoea
Gastrointestinal disorders
—
Septic shock
Infections and infestations
—
Mental status changes
Psychiatric disorders
—
Anaemia
Blood and lymphatic system disorders
—
Myocardial infarction
Cardiac disorders
—
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Multiple organ dysfunction syndrome
General disorders
—
Hepatic failure
Hepatobiliary disorders
—
Device related infection
Infections and infestations
—
Influenza
Infections and infestations
—
Staphylococcal bacteraemia
Infections and infestations
—
Platelet count decreased
Investigations
—
Failure to thrive
Metabolism and nutrition disorders
—
Hyponatraemia
Metabolism and nutrition disorders
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
Other adverse events (109 terms — click to expand)
The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
· Phase 4
· not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (
· Phase 2
· recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
· Phase 1
· not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
· Phase 1
· not yet recruiting
Other recruiting trials for Graft-versus-host Disease (GVHD)
Currently open trials in the same condition.
NCT06626737 — Dapagliflozin in Allo-HCT for aGVHD
· Phase 2
· recruiting
NCT06615050 — A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil
· Phase 3
· recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di
· Phase 2
· recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms
· Phase 1
· recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre
· Phase 3
· recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A
· Phase 1
· active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 24 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02953678.