Description:
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).
Title
- Brief Title: GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
- Official Title: GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Clinical Trial IDs
- ORG STUDY ID:
INCB 39110-309
- NCT ID:
NCT03584516
Conditions
- Chronic Graft-versus-host Disease
Interventions
| Drug | Synonyms | Arms |
|---|
| Itacitinib | INCB039110 | Part 1 : Dose determination of itacitinib |
| Placebo | | Part 1 : Dose expansion of itacitinib |
| Methylprednisolone | Medrol, Medrol Dosepak, Solu-Medrol | Part 1 : Dose determination of itacitinib |
| Prednisone | Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS | Part 1 : Dose determination of itacitinib |
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).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1 : Dose determination of itacitinib | Experimental | itacitinib administered in combination with corticosteroids. | - Itacitinib
- Methylprednisolone
- Prednisone
|
| Part 1 : Dose expansion of itacitinib | Experimental | itacitinib administered in combination with corticosteroids or corticosteroids alone. | - Itacitinib
- Placebo
- Methylprednisolone
- Prednisone
|
| Part 2 : itacitinib recommended dose from part 1 | Placebo Comparator | itacitinib or placebo administered in combination with corticosteroids | - Itacitinib
- Methylprednisolone
- Prednisone
|
Eligibility Criteria
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1 : Dose Determination: Number of dose-limiting toxicities |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD. |
Secondary Outcome Measures
| Measure: | Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids |
| Time Frame: | Up to 28 days |
| Safety Issue: | |
| Description: | Maximum observed concentration. |
| Measure: | Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids |
| Time Frame: | Up to 28 days |
| Safety Issue: | |
| Description: | Minimum observed plasma or serum concentration over the dose interval. |
Details
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Graft-versus-host-disease
- itacitinib
- Janus kinase inhibitor
- corticosteroids
Last Updated
August 4, 2021
