Phase 2
N=70
Itacitinib for Low Risk GVHD
Low Risk Acute Graft-versus-host Disease · Graft-versus-host-disease · GVHD
Bottom Line
View on ClinicalTrials.gov: NCT03846479 ↗Enrolled (actual)
70
Serious AEs
32.9%
Results posted
Feb 2023
Primary outcome: Primary: Number of Patients Who Achieve CR or PR by Day 28 of Treatment — 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Itacitinib (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- John Levine
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieve CR or PR by Day 28 of Treatment |
62 | — |
| PRIMARY Number of Participants Who Developed Steroid Refractory GVHD |
1 | — |
| SECONDARY Number of Participants With Serious Infectious |
19 | — |
| SECONDARY Number of Participants Alive at 6 Months and 1 Year |
66; 62 | — |
| SECONDARY Number of Participants With Non-relapse Mortality (NRM) |
2; 3 | — |
| SECONDARY Number of Participants Who Relapsed |
8; 12 | — |
| SECONDARY Number of Participants Who Developed Chronic GVHD |
18 | — |
| SECONDARY Cumulative Steroid Dose |
1.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed GVHD that meets criteria for Minnesota standard risk
- Ann Arbor 1 GVHD by biomarkers
- GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed)
- Any donor type, HLA-match, conditioning regimen is acceptable
- Age 12 - 75 years (children 500/μL and platelet count >20,000). Use of growth factor supplementation to maintain neutrophil count is allowed.
- Direct bilirubin must be 10 mg/day prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
- Patients who are pregnant
- Patients receiving investigational agents within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of itacitinib
- History of allergic reaction to itacitinib or any JAK inhibitor
Data sourced from ClinicalTrials.gov (NCT03846479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.