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NCT01028716 · OUTCOME

Percentage of Participants With Chronic Graft Versus Host Disease

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2023-01-23

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 2 years post-transplant

What was measured

Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.

Analysis population: Patients who were alive greater than day 100 were included

Groups in this outcome

Treatment (Nonmyeloablative HCT, TBI)

Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.

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 (Nonmyeloablative HCT, TBI)41

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nonmyeloablative HCT, TBI)26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.
groups
  1. description
    Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
    id
    OG000
    title
    Treatment (Nonmyeloablative HCT, TBI)
param Type
NUMBER
population Description
Patients who were alive greater than day 100 were included
reporting Status
POSTED
time Frame
Up to 2 years post-transplant
title
Percentage of Participants With Chronic Graft Versus Host Disease
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice