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New treatment option for Acute Graft-versus-host Disease
Official title MAGIC Ruxolitinib for aGVHD
ClinicalTrials.gov ID: NCT06936566
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute graft-versus-host disease.
Also referred to as Jakafi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- Patients who are pregnant or nursing
- History of allergic reaction to ruxolitinib or any JAK inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Fairway, Kansas, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.