GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Public ClinicalTrials.gov record NCT03139604. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
Study identification
- NCT ID
- NCT03139604
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 439 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2017 (Actual)
- Primary completion
- May 2, 2019 (Actual)
- Completion
- Jul 13, 2020 (Actual)
- Last update posted
- Sep 2, 2025
2017 – 2020
United States locations
- U.S. sites
- 49
- U.S. states
- 26
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Diego (UCSD) - Moores Cancer Center | La Jolla | California | 92093-0698 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California, Los Angeles (UCLA) - Medical Center | Los Angeles | California | 90095-1678 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| University of Colorado - Aurora Cancer Center | Aurora | Colorado | 80045 | — |
| University of Florida (UF) - Division of Hematology & Oncology | Gainesville | Florida | 32610 | — |
| University of Miami - Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Advocate Lutheran General Hospital - Oncology Specialists SC | Park Ridge | Illinois | 60028 | — |
| Indiana University (IU) Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Indiana Blood and Marrow Transplant | Indianapolis | Indiana | 46237 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| John Theurer Cancer Center At Hackensack UMC | Hackensack | New Jersey | 07601 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903-2681 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Columbia University | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Wake Forest Baptist Medical Center - Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Oncology Hematology in Cincinnati | Cincinnati | Ohio | 45236 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University (OSU) | Columbus | Ohio | 43210 | — |
| University of Oklahoma - Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239-3098 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Greenville Health System | Greenville | South Carolina | 29615 | — |
| Methodist Healthcare Foundation | Memphis | Tennessee | 38104 | — |
| Sarah Cannon Research Institute, LLC (SCRI) | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Transplant Institute | San Antonio | Texas | 78229 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03139604, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2025 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03139604 live on ClinicalTrials.gov.