Ruxolitinib treatment for acute graft-versus-host disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of ruxolitinib, a JAK inhibitor, for treating acute graft-versus-host disease (GVHD) that occurs after allogeneic hematopoietic cell transplantation. The study aims to evaluate the effectiveness of ruxolitinib in patients who have not responded to standard steroid treatments. Participants will be classified into standard and high-risk cohorts based on the Minnesota risk system, which predicts responses to treatment. The trial will assess the safety and efficacy of ruxolitinib in managing symptoms of GVHD, which can include skin rash, jaundice, nausea, vomiting, and diarrhea.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• Winship Cancer Institute, Emory University
  Atlanta, Georgia, United States Recruiting
• Kansas University Medical Center
  Fairway, Kansas, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: John Levine, MD, MS — Icahn School of Medicine at Mount Sinai
• Study coordinator: Rachel Young, BA
• Email: rachel.young@mssm.edu
• Phone: 646-937-1246

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Graft-versus-host disease after stem cell transplant: testing LBP-MARCO with ruxolitinib

  We are testing whether combining LBP-MARCO with ruxolitinib is safe for adults with GVHD after a stem cell transplant.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07913672

• DMR-001 in CALR-mutant myeloproliferative neoplasms

  This study tests DMR-001 alone for CALR-mutant essential thrombocythemia or myelofibrosis, and in combination with ruxolitinib for CALR-mutant myelofibrosis.

  Recruiting at 3 sites Phase 1 Damora Therapeutics · Birmingham, Alabama and 35 other locations · NCT07849231

• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

  This early-phase study tests whether WJ01024, by itself or with ruxolitinib, is safe and tolerable and whether it shows signs of activity in adults with myelofibrosis and enlarged spleen.

  Recruiting Phase 1 Henan Cancer Hospital · Zhengzhou, Henan · NCT07802405

• Belumosudil vs. Ruxolitinib for hepatic cGVHD after HSCT

  This trial tests whether belumosudil or ruxolitinib works better for hepatic chronic GVHD after a stem cell transplant in people 12 and older.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07794514

• Topical ruxolitinib for adults with pyoderma gangrenosum

  This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.

  Recruiting Phase 2 Oregon Health and Science University · Portland, Oregon · NCT07783412

• Ruxolitinib Cream Plus Corticosteroids for Facial Non-Segmental Vitiligo in Real-World Practice

  This real-world study tests whether adding 1.5% ruxolitinib cream to corticosteroids helps people 12 and older with active facial non-segmental vitiligo.

  Recruiting at 6 sites Dermavon Holdings Limited · Shenzhen, Guangdong and 19 other locations · NCT07673640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.