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NCT00079391 · OUTCOME

The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30

Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies · Source last updated 2015-10-26

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
Not reported
Time frame
Day 30

What was measured

The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30. Full chimerism is defined as \>95% donor alleles by molecular profiling (Short Tandem Repeat analysis).

Analysis population: Per protocol; only patients who survived to day 30 and were evaluable.

Groups in this outcome

Bone Marrow Transplantation Using Nexell Isolex 300i

Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.

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

Analysis denominator · Participants

GroupSource count
Bone Marrow Transplantation Using Nexell Isolex 300i49

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bone Marrow Transplantation Using Nexell Isolex 300i44.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44.9
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30. Full chimerism is defined as \>95% donor alleles by molecular profiling (Short Tandem Repeat analysis).
groups
  1. description
    Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
    id
    OG000
    title
    Bone Marrow Transplantation Using Nexell Isolex 300i
param Type
NUMBER
population Description
Per protocol; only patients who survived to day 30 and were evaluable.
reporting Status
POSTED
time Frame
Day 30
title
The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice