At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed GVHD meeting Minnesota standard risk criteria
- ✓Ann Arbor 1 GVHD by biomarkers
- ✓No prior systemic GVHD treatment (topical and non-absorbed steroids allowed)
- ✓Age 12-75 years; children <18 must weigh ≥50 kg
- ✕Currently receiving any JAK inhibitor, including ruxolitinib
- ✕Relapsed, progressing, or persistent malignancy requiring withdrawal of immune suppression
- ✕Uncontrolled infection (progressive despite treatment, persistent positive cultures, or severe sepsis)
- ✕Severe organ dysfunction: dialysis, mechanical ventilation, or oxygen >40% FiO2 within 7 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Itacitinib Monotherapy for Low Risk Graft-vs-Host Disease
In Brief
A Phase 2 clinical trial evaluating Itacitinib for Low Risk Acute Graft-versus-host Disease and 2 related conditions. Completed, enrolled 70 participants across 14 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
for up to 56 days