Participant flow

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2019-10-30

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

groups

1. description

   Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil \[MMF\] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO

   id

   FG000

   title

   Arm I (MMF and Tacrolimus)

2. description

   Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil \[MMF\] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO

   id

   FG001

   title

   Arm II (MMF and Tacrolimus Alternate Schedule)

3. description

   Patients receive tacrolimus and Mycophenolate Mofetil \[MMF\] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO

   id

   FG002

   title

   Arm III (MMF, Tacrolimus, and Sirolimus)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         71

      3. group Id

         FG002

         num Subjects

         69

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         71

      3. group Id

         FG002

         num Subjects

         69

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice