Participant flow

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease · Source last updated 2025-03-07

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

groups

1. description

   Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT

   id

   FG000

   title

   Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide

2. description

   Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV

   id

   FG001

   title

   Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         9

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         3

      type

      Relapse

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         108

      2. group Id

         FG001

         num Subjects

         27

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         17

      type

      Started: Single-cord Transplant

   3. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         10

      type

      Started: Double-cord Transplant

   4. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         10

      type

      Completed: Single-cord Transplant

   5. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         5

      type

      Completed: Double-cord Transplant

   6. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         15

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice