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NCT02259348 · FLOW

Participant flow

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation · Source last updated 2017-05-30

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

groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    FG000
    title
    Participants
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Donors
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      One Year Post-transplant
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Six enrolled participants were blood donors and did not undergo transplantation.
recruitment Details
Twelve participants meeting eligibility criteria were enrolled at St. Jude Children's Research Hospital between November 2014 and February 2015.
Complete source fields
groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    FG000
    title
    Participants
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Donors
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      One Year Post-transplant
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Six enrolled participants were blood donors and did not undergo transplantation.
recruitment Details
Twelve participants meeting eligibility criteria were enrolled at St. Jude Children's Research Hospital between November 2014 and February 2015.

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Preserved source evidence · Not medical advice