IRB #

STUDY00017140

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

Principal Investigator

Gabrielle Meyers

Study Purpose

You are invited to join in a clinical research study to find out if the oral drug, itacitinib is safe and effective in people who have acute graft-versus-host disease (GVHD).

Medical Condition(s)

Grade II to IV acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplant (allo-HSCT)

Eligibility Criteria

• Male or female, 18 years of age or older.
• Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder.
• Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
• Evidence of myeloid engraftment (eg, absolute neutrophil count ≥ 0.5 × 10^9/L for 3 consecutive days if ablative therapy was previously used).
• Be willing to avoid pregnancy or fathering children during this trial

Age Range

18 - 89

Healthy Volunteers Needed

No

Duration of Participation

Estimated Duration of Participation: participation is expected to average 12 months, which includes the following:
• A screening period lasting up to 28 days.
• A treatment period lasting as long as the subject is benefiting from treatment.
• A safety follow-up period lasting 30 to 35 days after treatment ends.
• A survival follow-up period lasting until death or study withdrawal.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

Incyte Corporation

Recruitment End

05/15/2027

Compensation Provided

No


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