So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
18
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
Henry Ford Hospital
Detroit, Michigan, United States
RECRUITINGMTD
The maximum tolerated dose
Time frame: day+30 post SCT
Incidence and severity of dose limiting toxicity (DLTs)
The overall incidence and severity of DLTs for uhCG/EGF
Time frame: day+30 post SCT
acute GVHD
Cumulative incidence of acute GVHD
Time frame: till day +100 post SCT
Chronic GVHD
Cumulative incidence of chronic GVHD
Time frame: one year post SCT
Overall survival
Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Time frame: one year post SCT
Disease free survival
Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events
Time frame: one year
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