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NCT00416884 · OUTCOME

Number of Participants With Treatment-related Mortality

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML · Source last updated 2017-09-27

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
lifetime followup, up to 100 years.

What was measured

Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding

Groups in this outcome

TBI, Campath, Fludarabine T-cell Deplete

(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0

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

Analysis denominator · Participants

GroupSource count
TBI, Campath, Fludarabine T-cell Deplete1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBI, Campath, Fludarabine T-cell Deplete0Not 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
      1
    units
    Participants
description
Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding
groups
  1. description
    (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
    id
    OG000
    title
    TBI, Campath, Fludarabine T-cell Deplete
param Type
NUMBER
reporting Status
POSTED
time Frame
lifetime followup, up to 100 years.
title
Number of Participants With Treatment-related Mortality
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice