Participant flow

T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts · Source last updated 2020-01-21

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

groups

1. description

   Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0

   id

   FG000

   title

   CLINIMACS Device

2. description

   Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0

   id

   FG001

   title

   ISOLEX Device

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         10

      type

      Relapse

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Subsequent transplant

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Treatment - hematopoietic cell product

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         28

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         11

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice