MAGIC Ruxolitinib for aGVHD (NCT06936566)
Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute GVHD
๐ฉบ Plain-English Summary (8th-Grade Level)
This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, vomiting, and/or diarrhea. The standard treatment for GVHD is high dose steroids such as prednisone or methylprednisolone, which suppresses the donor cells, but sometimes there can be either no response or the response does not last. In these cases, the GVHD can become dangerous or even life threatening. High dose steroid treatment can also cause serious complications. Researchers have developed a system, called the Minnesota risk system, to help predict how well the GVHD will respond to steroids based on the symptoms present at the time of diagnosis. The Minnesota risk system classifies patients with newly diagnosed acute GVHD into two groups with highly different responses to standard steroid treatment and long-term outcomes. This protocol maximizes efficiency because all patients with grade II-IV GVHD are eligible for screening and treatment is assigned according to patient risk. Patients with lower risk GVHD, Minnesota standard risk, have high response rates to steroid treatment. In this trial the researchers will test whether ruxolitinib alone is as effective (non-inferior) as steroid-free therapy and safe. Patients will be randomized to two different doses of ruxolitinib to identify the dose which maximizes efficacy while minimizing toxicities such as hematologic and infectious toxicities. Patients with higher risk GVHD, Minnesota high risk, have unacceptable outcomes with systemic corticosteroid treatment alone and the researchers will test whether adding ruxolitinib, a proven effective second line GVHD treatment, can improve outcomes when added to systemic corticosteroids as first line treatment.
Who can join: Review the eligibility criteria below.
Location: City of Hope Comprehensive Cancer Center โ Duarte, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (14 Sites)
- City of Hope Comprehensive Cancer Center โ Duarte, California
- Moffitt Cancer Center โ Tampa, Florida
- Winship Cancer Institute, Emory University โ Atlanta, Georgia
- Kansas University Medical Center โ Fairway, Kansas
- Massachusetts General Hospital โ Boston, Massachusetts
- Dana Farber Cancer Institute โ Boston, Massachusetts
- Mayo Clinic โ Rochester, Minnesota
- Washington University โ St Louis, Missouri
- Icahn School of Medicine at Mount Sinai โ New York, New York
- Ohio State University โ Columbus, Ohio
- University of Pennsylvania โ Philadelphia, Pennsylvania
- Vanderbilt University โ Nashville, Tennessee
- MD Anderson Cancer Center โ Houston, Texas
- Fred Hutchinson Cancer Research Center โ Seattle, Washington
๐ Contact the Study Coordinator
Phone: (646) 937-1246
Email: rachel.young@mssm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Graft-versus-host Disease
- Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease โ St Louis, Missouri
Explore by condition: All Acute Graft-versus-host Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.