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NCT00368355 · OUTCOME

Severe GVHD Rate

T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts · Source last updated 2020-01-21

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
95% Confidence Interval
Time frame
100 Days

What was measured

Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.

Analysis population: A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.

Groups in this outcome

CLINIMACS Device

Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0

ISOLEX Device

Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused 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
CLINIMACS Device10
ISOLEX Device23

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CLINIMACS Device0Not reported030.8Not reported
ISOLEX Device4.3Not reported0.121.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        30.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        21.9
        value
        4.3
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
    id
    OG000
    title
    CLINIMACS Device
  2. description
    Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
    id
    OG001
    title
    ISOLEX Device
param Type
NUMBER
population Description
A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.
reporting Status
POSTED
time Frame
100 Days
title
Severe GVHD Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice