GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Purpose
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Condition
- Chronic Graft-versus-host Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria - Underwent allogeneic stem cell transplantation (allo-HCT) - Karnofsky Performance Status score ≥ 60%. - Evidence of myeloid and platelet engraftment. - Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria
- Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD. - Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP). - Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization. - cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. - Evidence of relapsed primary malignancy.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- In Part 2 of the study, participants in the placebo group will be allowed to cross over to the experimental group after completion of the primary analysis.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Part 1 : Dose determination of itacitinib |
itacitinib administered in combination with corticosteroids. |
|
Experimental Part 1 : Dose expansion of itacitinib |
itacitinib administered in combination with corticosteroids or corticosteroids alone. |
|
Placebo Comparator Part 2 : itacitinib recommended dose from part 1 |
itacitinib or placebo administered in combination with corticosteroids |
|
Recruiting Locations
More Details
- NCT ID
- NCT03584516
- Status
- Terminated
- Sponsor
- Incyte Corporation