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NCT00089011 · OUTCOME

Rate and Duration of Steroid Use for the Treatment of Chronic GVHD

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer · Source last updated 2020-01-29

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 5 years

What was measured

Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.

Analysis population: Only those patients who received steroids for treatment of chronic GVHD.

Groups in this outcome

Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies

Arm II (Nonmyeloablative Conditioning With TBI)

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)44
Arm II (Nonmyeloablative Conditioning With TBI)21

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)78Not reported11156Not reported
Arm II (Nonmyeloablative Conditioning With TBI)89Not reported1420Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1156
        value
        78
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        420
        value
        89
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      21
    units
    Participants
description
Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.
dispersion Type
Full Range
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
  2. description
    Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
    id
    OG001
    title
    Arm II (Nonmyeloablative Conditioning With TBI)
param Type
MEDIAN
population Description
Only those patients who received steroids for treatment of chronic GVHD.
reporting Status
POSTED
time Frame
Up to 5 years
title
Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice