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Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant · Source last updated 2020-01-31

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

groups

1. description

   Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

   id

   FG000

   title

   Group 1A (Pentostatin, DLI Dose Level 1)

2. description

   Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

   id

   FG001

   title

   Group 1B (Pentostatin, DLI Dose Level 2)

3. description

   Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

   id

   FG002

   title

   Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)

4. description

   Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

   id

   FG003

   title

   Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      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

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice