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NCT00047060 · OUTCOME

Efficacy of Nonmyeloablative Preparative Regimen

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
36 months

What was measured

Proportion of subjects achieving a complete response. Complete response (CR) is defined as: disappearance of all signs and symptoms of cutaneous T-cell lymphomas (CTCL) for a period of at least one month.

Analysis population: Received a nonmyeloablative preparative regimen of alemtuzumab 30mg IV 3x a week for 2 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 w/target CSA levels in the therapeutic range (200 -400 ng/ml).

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

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Proportion of subjects achieving a complete response. Complete response (CR) is defined as: disappearance of all signs and symptoms of cutaneous T-cell lymphomas (CTCL) for a period of at least one month.
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
COUNT_OF_PARTICIPANTS
population Description
Received a nonmyeloablative preparative regimen of alemtuzumab 30mg IV 3x a week for 2 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 w/target CSA levels in the therapeutic range (200 -400 ng/ml).
reporting Status
POSTED
time Frame
36 months
title
Efficacy of Nonmyeloablative Preparative Regimen
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice