MAGIC Ruxolitinib for aGVHD (NCT06936566)
π©Ί 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: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).
Location: City of Hope Comprehensive Cancer Center β Duarte, California
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry
- Prior use of ruxolitinib to treat GVHD at any time
- Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression
- Relapse prior to development of GVHD unless subsequently in remission for at least 3 months
- GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval
- Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
- Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin β₯ 3x upper limit of normal not due to GVHD.
- A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD)
- Corticosteroids \>10 mg/day methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
- Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to β€grade 1
- Patients who are pregnant or nursing
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (14 Sites)
- City of Hope Comprehensive Cancer Center β Duarte, California
- Moffitt Cancer Center β Tampa, Florida
- Winship Cancer Institute, Emory University β Atlanta, Georgia
- Kansas University Medical Center β Fairway, Kansas
- Massachusetts General Hospital β Boston, Massachusetts
- Dana Farber Cancer Institute β Boston, Massachusetts
- Mayo Clinic β Rochester, Minnesota
- Washington University β St Louis, Missouri
- Icahn School of Medicine at Mount Sinai β New York, New York
- Ohio State University β Columbus, Ohio
- University of Pennsylvania β Philadelphia, Pennsylvania
- Vanderbilt University β Nashville, Tennessee
- MD Anderson Cancer Center β Houston, Texas
- Fred Hutchinson Cancer Research Center β Seattle, Washington
π° 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 Β§ 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.