West Cancer Center

ALLO-HCT: Supportive Care: GVHD tx: GRAVITAS-301

GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Title

Incyte 39110-301 (GVHD)

Study Title

GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Site Link

NCT03139604

Malignancy

Leukemia, Lymphoma, Sickle-cell disease, aplastic anemia

Stage

Stage 4

Disease Setting

Post-allogeneic stem cell transplant

Line Of Therapy

First line GVHD

Investigational Agent

Itacitinib

Drug Class

JAK-1 inhibitor

Yasir Khaled, MD

Sponsor

Incyte Corporation

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Has undergone 1 allogeneic stem cell transplant from any type of donor and any donor source for hematologic disorder. Recipients of myeloablative and reduced-intesity conditioning regimens are eligible
Clinically suspected Grade II to IV aGVHD per MAGIC criteria
Evidence of myeloid engraftment
Creatinine <2
No more than 1 prior aHCT
No more than 2 days of steroids for GVHD
No presence of GVHD overlap syndrome
No active HBV or HCV
No known HIV
No relapse of underlying malignancy post aHCT

Objective

Primary- Overall response rate by CIBMTR response index. Secondary- nonrelapse mortality, DoR, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

N/A

Dosing Frequency

Control Agents

placebo

Study Protocol

Randomized

Yes