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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.
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 .
TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.
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.
All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.
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).
Given on day 0.
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGOverall Survival
Evaluate rates of overall survival at 100 days after transplant.
Time frame: Day 100
Transplant Related Mortality
● Estimate transplant related mortality (TRM) at 100 days and 1 year with this conditioning and GVHD prophylaxis combination
Time frame: Day 100 and 1 year
Overall Survival
Estimate overall survival at 1 and 2 years
Time frame: 1 and 2 years
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