Status:
RECRUITING
MAGIC Ruxolitinib for aGVHD
Lead Sponsor:
John Levine
Collaborating Sponsors:
Incyte Corporation
National Cancer Institute (NCI)
Conditions:
Acute Graft-versus-host Disease
Allogeneic Bone Marrow Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 14 2028
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06936566
Start Date
May 14 2025
End Date
April 14 2028
Last Update
May 31 2025
Active Locations (11)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114