Actively Recruiting
Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute Graft-versus-Host Disease
Led by John Levine · Updated on 2026-03-23
98
Participants Needed
14
Research Sites
45 weeks
Total Duration
On this page
Sponsors
J
John Levine
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ruxolitinib-based treatments for acute graft-versus-host disease (GVHD) that occurs after allogeneic hematopoietic cell transplant. Acute GVHD happens when donor cells attack the recipient's healthy tissues, causing symptoms like skin rash, jaundice, nausea, vomiting, and diarrhea. Standard treatment involves high-dose steroids, but responses can be insufficient or temporary, and steroids may cause serious complications. This phase 2 trial uses the Minnesota risk system to classify patients into standard or high risk groups based on their GVHD symptoms, aiming to test new ruxolitinib dosing strategies and combinations to improve outcomes. Participants are assigned to one of three treatment groups based on their risk status. Patients with standard risk receive either a lower or higher dose of oral ruxolitinib twice daily for 56 days followed by tapering doses if no progression or toxicity occurs. High risk patients receive the higher dose of ruxolitinib along with systemic corticosteroids (methylprednisolone or similar) starting at 2 mg/kg/day for at least three days before tapering. Researchers aim to identify the dose that balances effectiveness with fewer side effects such as blood or infection-related toxicities. During the study, participants are monitored for treatment response at day 28 and other outcomes including steroid-refractory GVHD at 28 days, durable response at 56 days, GVHD flares, corticosteroid use, chronic GVHD requiring steroids, overall survival, non-relapse mortality, and relapse over one year. Assessments include clinical evaluations and ongoing safety monitoring. The study lasts at least one year to observe long-term effects and survival, with careful follow-up to evaluate the impact of ruxolitinib-based therapies on acute GVHD.
CONDITIONS
Brief Title
MAGIC Ruxolitinib for aGVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minnesota standard risk GVHD patients with grade II-IV disease (excluding grade I with less than 50% body surface rash)
- Minnesota high risk GVHD patients, including those with GVHD after donor lymphocyte infusion for mixed chimerism or poor graft function
- No prior systemic treatment for acute GVHD; topical or non-absorbed steroids allowed
- All donor types, HLA matches, conditioning regimens, and GVHD prevention methods accepted
- Age 18 years or older
- For standard risk: hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000/µL and platelet count ≥ 20,000; growth factors and transfusions allowed
- For high risk: hematopoietic engraftment with ANC ≥ 500/µL and platelet count ≥ 20,000; growth factors and transfusions allowed
You will not qualify if you...
- Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days before study entry
- Prior use of ruxolitinib for GVHD treatment
- Relapsed, progressing, or persistent cancer requiring stopping immunosuppression
- Relapse before GVHD unless in remission for at least 3 months
- GVHD after donor lymphocyte infusion for relapse without approval
- Uncontrolled infection despite treatment or severe sepsis
- Severe organ failure within 3 days before enrollment including need for dialysis, mechanical ventilation, continuous BiPAP, or high flow oxygen, or high bilirubin not due to GVHD
- Signs of chronic GVHD or overlap syndrome at enrollment (except mild oral or eye symptoms)
- Use of corticosteroids over 10 mg/day methylprednisolone equivalent within 5 days before GVHD onset, except for adrenal insufficiency or premedication
- Participation in other experimental drug trials within 14 days or five half-lives, whichever is longer, with improved adverse events
- Pregnancy or nursing
- Allergic reaction history to ruxolitinib or any JAK inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days of treatment plus approximately 2 weeks of tapering
Participants receive ruxolitinib orally twice daily for 56 days followed by a taper period. Some participants also receive systemic corticosteroids starting at a high dose for at least three days with a taper depending on response and tolerance.
Visits occur regularly during the 8-week treatment period
Duration - Up to 1 year
Participants are monitored for treatment response, GVHD flares, corticosteroid use, survival, and other health outcomes.
Periodic visits over 1 year for assessment
Trial Site Locations
Total: 14 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
3
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Kansas University Medical Center
Fairway, Kansas, United States, 66205
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Washington University
St Louis, Missouri, United States, 63110
Not Yet Recruiting
9
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Ohio State University
Columbus, Ohio, United States, 43210
Not Yet Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
Vanderbilt University
Nashville, Tennessee, United States, 37235
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
Rachel Young, BA
J
Janna Baez, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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