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NCT01596257 · OUTCOME

Median Time to Engraftment of Neutrophils

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.

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to 100 weeks

What was measured

Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L

Groups in this outcome

Bulk Stem Cell Transplantation/SCT

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

Fractionated Stem Cell Transplantation/SCT

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bulk Stem Cell Transplantation/SCT38
Fractionated Stem Cell Transplantation/SCT36

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bulk Stem Cell Transplantation/SCT11Not reported922Not reported
Fractionated Stem Cell Transplantation/SCT11Not reported922Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        22
        value
        11
      2. group Id
        OG001
        lower Limit
        9
        upper Limit
        22
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      36
    units
    Participants
description
Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L
dispersion Type
Full Range
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
    OG000
    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
    OG001
    title
    Fractionated Stem Cell Transplantation/SCT
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 100 weeks
title
Median Time to Engraftment of Neutrophils
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice