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NCT00368355 · OUTCOME

Early Post BMT Toxicities

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
100 Days

What was measured

Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)

Analysis population: Of the 46 participants at baseline, one participant in CLINIMACS Device group did not undergo haploidentical stem cell transplant and was 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 Device17
ISOLEX Device28

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CLINIMACS Device14Not reportedNot reportedNot reportedNot reported
ISOLEX Device14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
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
COUNT_OF_PARTICIPANTS
population Description
Of the 46 participants at baseline, one participant in CLINIMACS Device group did not undergo haploidentical stem cell transplant and was not included in this analysis.
reporting Status
POSTED
time Frame
100 Days
title
Early Post BMT Toxicities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice