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De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Sponsor: Medical College of Wisconsin
Summary
This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.
Official title: A Phase II Trial of De-escalated PTCy and Ruxolitinib for GVHD Prophylaxis in Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2023-08-29
Completion Date
2026-09
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
25 mg/kg by IV on Days +3 and +4.
Tacrolimus
Target level 5-10 ng/mL (If the subject experiences nausea and vomiting that prevents the oral intake of tacrolimus anytime during treatment, tacrolimus is to be given by IV at the appropriate dose that was used to obtain the therapeutic level \[IV:PO ratio = 1:4\]). Administered Days +5 through +90. Taper after Day +90 and discontinue on Day +180.
Mycophenolate Mofetil
15 mg/kg tablet thrice daily Days +5 through +35 every eight hours.
Ruxolitinib
5 mg tablet twice daily after engraftment through Day +365. Taper after Day +365.
Locations (1)
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States