MAGIC Ruxolitinib for aGVHD

Launched by JOHN LEVINE · Apr 12, 2025

Keywords

ClinConnect Summary

This clinical trial, called MAGIC Ruxolitinib for aGVHD, is exploring a new treatment approach for acute graft-versus-host disease (GVHD) that can occur after a bone marrow transplant. In GVHD, the donor's immune cells can mistakenly attack the recipient's healthy tissues, leading to symptoms like skin rashes, jaundice (yellowing of the skin), nausea, vomiting, and diarrhea. The usual treatment involves high doses of steroids, but not everyone responds well to this, and it can sometimes lead to serious side effects. This study aims to see if ruxolitinib, a medication that targets specific pathways in the immune system, is as effective and safe as steroid treatments, especially for patients with higher risk GVHD.

To be eligible for this trial, participants should be at least 18 years old and have been diagnosed with GVHD that is classified as either standard or high risk according to a specific system known as the Minnesota risk system. They should not have received any prior systemic treatment for acute GVHD. Participants will be randomly assigned to receive different doses of ruxolitinib, and those with higher risk GVHD may receive it along with steroids. Throughout the study, participants will be closely monitored for their health and any side effects. This trial offers a potential new option for patients who may not respond well to standard steroid treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I \[\<50% BSA rash\])
• • High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed
• • No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted.
• • All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable
• • ≥18 years of age
• • Standard risk cohort: Hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000/μL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.
• • High risk cohort: Hematopoietic engraftment with ANC ≥ 500/uL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.
• 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 ≥ 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 ≤grade 1
• • Patients who are pregnant or nursing
• • History of allergic reaction to ruxolitinib or any JAK inhibitor