Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT06936566
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06936566
Study Brief:
Protocol Section:
NCT06936566