Leukemia,
Lymphoma,
Multiple Myeloma,
Myelodysplastic Syndrome
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
Methylprednisolone,
Ruxolitinib
Kitko, Carrie
National
Vanderbilt University
12-10-2025
Eligibility
Not Available
Not Available
Not Available
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/L 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
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/L 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
