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NCT00787761 · OUTCOME

T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)

Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer · Source last updated 2012-10-01

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
180 days

What was measured

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.

Analysis population: 20 of the patients treated on study had chimerism drawn on day 180.

Groups in this outcome

RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan

All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6

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

Analysis denominator · Participants

GroupSource count
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan20

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
groups
  1. description
    All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
    id
    OG000
    title
    RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
param Type
NUMBER
population Description
20 of the patients treated on study had chimerism drawn on day 180.
reporting Status
POSTED
time Frame
180 days
title
T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice