To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells
Karnofsky status >/= 70%
Hematologic malignancy requiring allogeneic transplantation
First allogeneic transplant only. Prior autologous transplant is allowed.
Poor cardiac function: LVEF <40%
Poor pulmonary function: FEV1 and FVC <50% predicted
Poor liver function: bilirubin >/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy)
Poor renal function: Creatinine >/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) <40mL/min based on Traditional Cockcroft-Gault formula
Single group
Tacrolimus
DrugBegins Day -1 and continues to Day +90 or Day +180 after transplant
Cyclophosphamide
DrugGiven Days +3 and +4 after transplant
Mycofenolate mofetil
DrugGiven Day 0 to Day +35 after transplant
Efficacy in preventing CRS post transplant
Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0.
Severity of CRS after stem cell transplant
Record incidence of CRS by grading signs and symptoms using the CTCAE v5.0, the day of onset of CRS, the duration of CRS, and admissions to the hospital for these events
Safety of administering early immunosuppression
Record incidence of acute graft-versus-host disease at 6 months by using the NIH Grading Consensus system
Safety of administering early immunosuppression
Record incidence of chronic graft-versus-host disease at 1 year by using the NIH Grading Consensus system
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