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NCT00709592 · FLOW

Participant flow

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT · Source last updated 2018-11-09

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

groups
  1. description
    1.7 mg/kg/d thymoglobulin IV d-9 to -7
    id
    FG000
    title
    A:Thymoglobulin: 1.7 mg/kg/Day
  2. description
    2.5 mg/kg/d thymoglobulin IV d-9 to d-7
    id
    FG001
    title
    B:Thymoglobulin: 2.5 mg/kg/Day
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unable to proceed to transplant
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        22
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomized to rabbit ATG (Thymoglobulin; Genzyme, Cambridge, MA), 2.5 or 1.7 mg/kg adjusted ideal body weight/day, followed by TBI to a total dose of 4.5 Gy. Methylprednisolone 2 mg/kg given pre-medication for ATG. GVHD prophylaxis was tacrolimus starting at approximately 12 weeks post transplantation.
recruitment Details
Consecutive patients enrolled have recurrent or high-risk hematologic malignancy, adequate end-organ function and performance status. Patient required to have 7/8 or 8/8 mismatched related donor (MRD) or unrelated donor (URD), with high-resolution typing performed for HLA-A, -B, -C, and -DRB1.
Complete source fields
groups
  1. description
    1.7 mg/kg/d thymoglobulin IV d-9 to -7
    id
    FG000
    title
    A:Thymoglobulin: 1.7 mg/kg/Day
  2. description
    2.5 mg/kg/d thymoglobulin IV d-9 to d-7
    id
    FG001
    title
    B:Thymoglobulin: 2.5 mg/kg/Day
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unable to proceed to transplant
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        22
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomized to rabbit ATG (Thymoglobulin; Genzyme, Cambridge, MA), 2.5 or 1.7 mg/kg adjusted ideal body weight/day, followed by TBI to a total dose of 4.5 Gy. Methylprednisolone 2 mg/kg given pre-medication for ATG. GVHD prophylaxis was tacrolimus starting at approximately 12 weeks post transplantation.
recruitment Details
Consecutive patients enrolled have recurrent or high-risk hematologic malignancy, adequate end-organ function and performance status. Patient required to have 7/8 or 8/8 mismatched related donor (MRD) or unrelated donor (URD), with high-resolution typing performed for HLA-A, -B, -C, and -DRB1.

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Preserved source evidence · Not medical advice