This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
Baptist Health South Florida/Miami Cancer Institute
Miami, Florida, United States
Incidence rate of graft versus host disease (GvHD)
Incidence of acute and chronic GvHD
Time frame: Two years
Severity of disease
Severity of the adverse events will be reported based on the CTCAE Version 5.
Time frame: Two years
Incidence of transplant-related mortality (TRM)
TRM includes fatal complications resulting from the allogeneic transplant and/ or treatment regimens such as graft failure, GvHD, hemorrhages, and infections.
Time frame: Two years
Change in overall survival (OS)
OS is defined as time from transplant to death or last follow-up.
Time frame: Six months, one year, two years
Change in disease free survival (DFS)
DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow- up, from the time of transplant.
Time frame: Six months, one year, two years
Proportion of patients optimal and suboptimal doses
The proportion of patients receiving optimal cell doses (CD34+: \>5x 10\^6/kg and CD3+: \< 5 x10\^4/kg) and suboptimal doses (CD34+: \<3 x 10\^6/kg and CD3+: \>5 x 10\^4/kg).
Time frame: Two years
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Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
Melphalan: 70 mg/m\^2/day x 2
Fludarabine: 25 mg/m\^2/day x 5