Participant flow

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD · Source last updated 2026-06-01

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

groups

1. description

   HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

   id

   FG000

   title

   Arm A (MRD / High Intensity Conditioning)

2. description

   LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

   id

   FG001

   title

   Arm B (MRD / Low Intensity Conditioning)

3. description

   HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

   id

   FG002

   title

   Arm C (MUD / High Intensity Conditioning)

4. description

   LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

   id

   FG003

   title

   Arm D (MUD / Low Intensity Conditioning)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         18

      type

      Alive at Day 28 post transplant

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         17

      4. group Id

         FG003

         num Subjects

         18

      type

      Alive at Day 100 post transplant

   4. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         15

      type

      Alive at 1 year post transplant

   5. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         14

      type

      Alive at 2 years post transplant

   6. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         14

      type

      Alive at 3 years post transplant

   7. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         14

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 84 enrolled participants, only 77 received naïve T-cell deplete grafts. 6 out of the 7 remaining participants received unmanipulated grafts, 5 because cell selection precluded inadequate donor CD34 cells, and 1 because cell selection was unsuccessful. The seventh participant switched to cord blood transplant because the donor became medically unavailable after the patient had begun conditioning. Characteristics and outcomes of these patients are in table S2 and S10 of JCO paper.

recruitment Details

Participants were recruited based on referral for Hematopoietic Cell Transplant at Fred Hutchinson Cancer Center and University of Pittsburgh Medical Center between July 2014 and March 2020. The first participant enrolled on March 23, 2015 and the last participant enrolled on March 11, 2020.

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Preserved source evidence · Not medical advice