Participant flow

Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2021-06-03

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

groups

1. description

   CONDITIONING REGIMEN: Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients with related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC

   id

   FG000

   title

   Arm A (Treosulfan, Fludarabine Phosphate)

2. description

   CONDITIONING REGIMEN: Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0. TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Fludarabine Phosphate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Total-Body Irradation

   id

   FG001

   title

   Arm B (Treosulfan, Fludarabine Phosphate, TBI)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      protocol changed due SC changed to cord

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         67

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         65

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice