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NCT01596257 · FLOW

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Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation · Source last updated 2022-12-29

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

groups
  1. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    FG000
    title
    Bulk Stem Cell Transplantation/SCT
  2. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    FG001
    title
    Fractionated Stem Cell Transplantation/SCT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        19
      type
      Inadequate Collection
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        36
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study goal was to explore fractionated HPC infusion in humans in a setting of commonly used conditioning regimens. The design included stratification of randomization by transplant type. Additional stratification would have increased the accrual target for statistical power, prolonging enrollment. In our publication reporting results of this trial (Tamari et al. JTCT 2021) we provide data stratified by treatment arm and transplant type for secondary endpoints for easier interpretation.
Complete source fields
groups
  1. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    FG000
    title
    Bulk Stem Cell Transplantation/SCT
  2. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    FG001
    title
    Fractionated Stem Cell Transplantation/SCT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        19
      type
      Inadequate Collection
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        36
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study goal was to explore fractionated HPC infusion in humans in a setting of commonly used conditioning regimens. The design included stratification of randomization by transplant type. Additional stratification would have increased the accrual target for statistical power, prolonging enrollment. In our publication reporting results of this trial (Tamari et al. JTCT 2021) we provide data stratified by treatment arm and transplant type for secondary endpoints for easier interpretation.

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

Preserved source evidence · Not medical advice