At a glance
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Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies
In Brief
A Phase 2 clinical trial evaluating Total Body Irradiation, Cyclophosphamide, and 5 other interventions for Hematological Malignancies. Completed, enrolled 78 participants across 1 site.
Detailed Summary
It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.
Study Details
Timeline
Interventions
Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy) Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)