Actively Recruiting
Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation
Led by City of Hope Medical Center · Updated on 2026-04-20
42
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies how well biomarker-guided ruxolitinib works for the prevention of chronic graft versus host disease (GVHD) in patients that have undergone allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is the most effective therapy for patients with high-risk blood and bone marrow malignancies. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. In chronic GVHD (cGVHD), symptoms occur more than three months after transplantation. Despite significant advances in how allogeneic HCTs are conducted, cGHVD remains a major limitation to the long-term success of the transplant and can impact patients' quality of life post-transplant. Checking GVHD biomarkers in patients' blood after allogeneic HCT may help doctors predict how likely the patient is to develop cGVHD. This information can be used to help guide patients with high levels to receive cGVHD preventative therapy with ruxolitinib. Ruxolitinib works by blocking some of the enzymes that are needed for the development of cGVHD, which may be an effective way to prevent cGVHD in patients with high levels of GVHD biomarkers.
CONDITIONS
Official Title
Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent or assent as appropriate
- Age 18 years or older
- Karnofsky performance status of 80 or higher
- Received allogeneic hematopoietic cell transplantation with peripheral blood stem cells
- In morphologic remission by day +30 bone marrow evaluation
- Any conditioning regimen allowed
- Any GVHD prophylaxis allowed
- Life expectancy greater than 6 months
- Absolute neutrophil count above 1000/mm^3 between day +70 and +100 post-transplant
- Hemoglobin level 8.0 gm/dL or higher between day +70 and +100 post-transplant
- Platelet count 50,000/mm^3 or higher between day +70 and +100 post-transplant (exceptions if certain infections are actively treated)
- Total bilirubin less than or equal to 1.5 times upper limit of normal unless Gilbert's disease
- AST and ALT less than or equal to 3 times upper limit of normal between day +70 and +100
- Glomerular filtration rate 50 ml/min or higher between day +70 and +100
- Women of childbearing potential with negative pregnancy test between day +70 and +100
- Agreement to use effective birth control or abstain from heterosexual activity during study and 3 months after
- For patients with elevated GVHD biomarkers after day +100: elevated ST2, CXCL9, MMP-3, and OPN levels
- No use of ruxolitinib or other JAK inhibitors in past 14 days
- Morphologic remission at day +100 bone marrow
- Adequate hematopoietic recovery (hemoglobin ≥ 8 g/dL, platelets ≥ 50K/mm^3)
- Absence of active infection not responding to antibiotics
- Absence of progressive acute GVHD except low-dose prednisone (<0.25 mg/kg)
- Absence of significant uncontrolled illness
You will not qualify if you...
- Chemotherapy within 14 days prior to study biospecimen collection at day +100 post-transplant
- Use of ruxolitinib or other JAK inhibitors within 14 days before enrollment
- History of allergic reactions to similar compounds as study drug
- Active or progressive acute GVHD requiring medication other than low-dose prednisone (<0.25 mg/kg)
- Major cardiovascular events or thrombosis (MI, stroke, PE, DVT) in past 6 months
- History of tuberculosis
- Clinically significant uncontrolled illness
- Active infection not responding to antibiotics
- Other active malignancy that could interfere with study assessments
- Female participants who are pregnant or breastfeeding
- Any condition judged by investigator to contraindicate participation for safety reasons
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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