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NCT01427881 · OUTCOME

Graft Failure

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies · Source last updated 2017-05-19

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
By greater than or equal to 28 days post-transplant

What was measured

Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.

Groups in this outcome

Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)

PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT

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

Analysis denominator · Participants

GroupSource count
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)43

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    id
    OG000
    title
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
param Type
NUMBER
reporting Status
POSTED
time Frame
By greater than or equal to 28 days post-transplant
title
Graft Failure
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice