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.
|
-
Drug: Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Other names:
-
Drug: Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Medrol, Medrol Dosepak, Solu-Medrol
-
Drug: Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS
|
Experimental Part 1 : Dose expansion of itacitinib
|
itacitinib administered in combination with corticosteroids or corticosteroids alone.
|
-
Drug: Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Other names:
-
Drug: Placebo
In Part 2, participants will receive matching placebo.
-
Drug: Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Medrol, Medrol Dosepak, Solu-Medrol
-
Drug: Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS
|
Placebo Comparator Part 2 : itacitinib recommended dose from part 1
|
itacitinib or placebo administered in combination with corticosteroids
|
-
Drug: Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Other names:
-
Drug: Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Medrol, Medrol Dosepak, Solu-Medrol
-
Drug: Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other names:
- Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS
|
More Details
- Status
- Terminated
- Sponsor
- Incyte Corporation
Study Contact