Adults 12 to 75, any sex, with Low Risk Acute Graft-versus-host Disease or Graft-versus-host-disease. 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.
Number of Patients Who Achieve CR or PR by Day 28 of TreatmentPrimary· Day 28
Number of patients who achieve CR or PR by day 28 of treatment with itacitinib without the addition of any other systemic GVHD treatment including steroids.
Complete Response (CR): All evaluable organs (skin, liver, GI tract) stage 0. For a response to be scored as CR on day 28, the patient must be in CR on that day and have had no intervening additional GVHD therapy.
Partial Response (PR): An improvement in one or more organ involved with GVHD symptoms without worsening in others. For a response to be scored as PR on day 28, the patient must be in PR on that day and have had no intervening
Group
Value
95% CI
Low Risk GVHD Patients Treated
62
Number of Participants Who Developed Steroid Refractory GVHDPrimary· Day 28
Number of participants who developed steroid refractory GVHD within 28 days of starting steroids. Steroid-refractory GVHD (defined as GVHD that worsens (increase by one or more grade) after 3 days, or fails to respond to treatment within 7 days (for GVHD grade III) or 14 days (for GVHD grade II) or 2nd line therapy beyond systemic steroid treatment is begun within 28 days of starting steroids.
Group
Value
95% CI
Low Risk GVHD Patients Treated
1
Number of Participants With Serious InfectiousSecondary· Day 90
Number of participants who developed serious infections by day 90. Serious infectious complications is defined as any viral and bacterial infections requiring treatment and proven fungal infections.
Group
Value
95% CI
Low Risk GVHD Patients Treated
19
Number of Participants Alive at 6 Months and 1 YearSecondary· 6 months and 1 year
Number of overall survival (OS), defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
6 months
Group
Value
95% CI
Low Risk GVHD Patients Treated
66
1 year
Group
Value
95% CI
Low Risk GVHD Patients Treated
62
Number of Participants With Non-relapse Mortality (NRM)Secondary· 6 months and 1 year
Number of participants with non-relapse mortality (NRM) at 6 months and 1 year
6 months
Group
Value
95% CI
Low Risk GVHD Patients Treated
2
1 year
Group
Value
95% CI
Low Risk GVHD Patients Treated
3
Number of Participants Who RelapsedSecondary· 6 months and 1 year
Number of participants who relapsed by 6 months and by 1 year
6 months
Group
Value
95% CI
Low Risk GVHD Patients Treated
8
1 year
Group
Value
95% CI
Low Risk GVHD Patients Treated
12
Number of Participants Who Developed Chronic GVHDSecondary· 1 year
Number of participants who developed chronic GVHD requiring systemic treatment at 1 year
Group
Value
95% CI
Low Risk GVHD Patients Treated
18
Cumulative Steroid DoseSecondary· Day 28
Cumulative steroid dose (over 4 weeks) in patients who receive steroids as second line therapy
Group
Value
95% CI
Low Risk GVHD Patients Treated
1.9
± 0.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days for Adverse Events 1 year for All-Cause Mortality.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Low Risk GVHD Patients Treated
Serious: 23/70 (33%)
Deaths: 8/70
Serious adverse events (24 terms)
Reaction
System
Low Risk GVHD Patients Tre…
Relapse
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05660421 — Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
· Phase 2
· withdrawn
NCT05364762 — Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergo
· Phase 2
· active not recruiting
NCT05063110 — Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB
· Phase 2
· completed
NCT04859946 — Itacitinib for the Prevention of Graft Versus Host Disease
· Phase 2
· active not recruiting
NCT04239989 — Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant
· Phase 1
· terminated
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 John Levine
Last refreshed: 6 February 2023
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/NCT03846479.