Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
Status:
Active, not recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the
post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The
primary objective is to determine the incidence of grade II-IV acute GVHD following
Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide
(cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and
mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination
of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the
safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation.
Disease recurrence and time to recurrence in patients receiving post-transplant
cyclophosphamide compared to historical control without post-transplant cyclophosphamide
(cytoxan) will also be evaluated. Other objectives will be to determine the time of onset,
severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as
observation of Immune Reconstitution over time.