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MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Sponsor: Masonic Cancer Center, University of Minnesota
Summary
This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.
Key Details
Gender
All
Age Range
2 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-08
Completion Date
2035-03
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Treosulfan
12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.
Fludarabine
Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .
Total Body Irradiation
TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.
Tacrolimus
Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL.
Mycophenolate Mofetil
All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.
Cyclophosphamid
Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).
Stem Cell Infusion
Given on day 0.