Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
Condition: Leukemia; Lymphoma; Myelodysplastic Syndrome; Myelofibrosis; Severe Aplastic Anemia; Allogeneic Transplant
MeSH terms: Lymphoma; Leukemia; Preleukemia; Myelodysplastic Syndromes; Primary Myelofibrosis; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      he 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.
    

Intervention name(s): Cyclophosphamide
Intervention type(s): Drug
Other intervention name(s): Cytoxan
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: acute myeloid leukemia; AML; acute lymphoblastic leukemia; ALL; chronic myeloid leukemia; CML; chronic lymphocytic leukemia; CLL; non-Hodgkin lymphoma; NHL; Hodgkin lymphoma; HL; myelodysplastic syndrome; MDS; myelofibrosis; severe aplastic anemia