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NCT01028716 · OUTCOME

Incidence of Primary Graft Failure

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At day 84

What was measured

Defined as \< 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.

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)45

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nonmyeloablative HCT, TBI)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Defined as \< 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At day 84
title
Incidence of Primary Graft Failure
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice