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NCT03139604 · ClinicalTrials.gov registry record · Phase 3
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
A Phase 3 study of Graft-versus-host Disease (GVHD), sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
- 20
- Study locations
NCT03139604: Completed Phase 3 study of Graft-versus-host Disease (GVHD), sponsored by Incyte Corporation.
NCT03139604 is a Phase 3 study of Graft-versus-host Disease (GVHD) that has completed, run by Incyte Corporation. The registered enrollment target is 439 participants, above the 249-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03139604, a Phase 3 study of Graft-versus-host Disease (GVHD), has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG Itacitinib
Study Locations (20)
California
- University of California, San Diego (UCSD) - Moores Cancer Center - La Jolla
- University of Southern California - Los Angeles
- University of California, Los Angeles (UCLA) - Medical Center - Los Angeles
- Stanford Cancer Center - Stanford
Florida
- University of Florida (UF) - Division of Hematology & Oncology - Gainesville
- University of Miami - Sylvester Cancer Center - Miami
- Florida Hospital Cancer Institute - Orlando
Illinois
- University of Illinois at Chicago - Chicago
- University of Chicago - Chicago
- Advocate Lutheran General Hospital - Oncology Specialists SC - Park Ridge
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Indiana
- Indiana University (IU) Melvin and Bren Simon Cancer Center - Indianapolis
- Indiana Blood and Marrow Transplant - Indianapolis
Colorado
- University of Colorado - Aurora Cancer Center - Aurora
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Cancer Center - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2020-07-13 |
| Phase | Phase 3 |
What the finished NCT03139604 record still lists
NCT03139604 is an interventional study that assigns participants to a tested intervention. The registered 439 participants enrollment target is mid-sized for trials with a published cap, above the 249-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (76% higher).
The record links to 1 condition, with Graft-versus-host Disease (GVHD) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03139604 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03139604 about?
NCT03139604 is a clinical study titled "GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease". 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).
What is the current status of trial NCT03139604?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2017-07-19. Estimated completion is 2020-07-13.
What conditions does trial NCT03139604 study?
This clinical trial studies the following conditions: Graft-versus-host Disease (GVHD).
What interventions are being tested in trial NCT03139604?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), Itacitinib (DRUG).
Who is sponsoring clinical trial NCT03139604?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03139604 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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