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NCT00047060 · OUTCOME

Median Time in Months to Achieve Full Myeloid and Full Donor T-cell Chimerism

Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome · Source last updated 2023-11-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Up to 22 months

What was measured

Median time in months to achieve full myeloid and full donor T-cell Chimerism. Myeloid (CD34+) and T-cell (CD3+) chimerisms were determined by PCR analysis of short tandem repeats (STR). Full donor chimerism is defined as \>95% donor- derived cells in the peripheral blood in a specific lineage.

Groups in this outcome

Stem Cell Transplant Therapy With Campath-1H

Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m\^2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x10\^6 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).

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

Analysis denominator · Participants

GroupSource count
Stem Cell Transplant Therapy With Campath-1H5

Reported measurements

Myeloid Chimerism
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H9Not reported318Not reported
Donor T-cell Chimerism
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H7Not reported422Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        18
        value
        9
    title
    Myeloid Chimerism
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        22
        value
        7
    title
    Donor T-cell Chimerism
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Median time in months to achieve full myeloid and full donor T-cell Chimerism. Myeloid (CD34+) and T-cell (CD3+) chimerisms were determined by PCR analysis of short tandem repeats (STR). Full donor chimerism is defined as \>95% donor- derived cells in the peripheral blood in a specific lineage.
dispersion Type
Full Range
groups
  1. description
    Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv three times a week for two weeks followed by fludarabine 25mg/m\^2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x10\^6 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).
    id
    OG000
    title
    Stem Cell Transplant Therapy With Campath-1H
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 22 months
title
Median Time in Months to Achieve Full Myeloid and Full Donor T-cell Chimerism
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice