Participant flow

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG · Source last updated 2017-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.

   id

   FG000

   title

   Autologous-Allogeneic Hematopoietic Stem Cell Transplant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lack of suitable allogeneic donor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         9

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice