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NCT00047060 · OUTCOME

Overall Response

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
Up to 3 years

What was measured

Overall response following stem cell transplant. 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. Partial response (PR) - a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 50% reduction in area of disease involvement in the case of cutaneous disease) lasting for a period of at least one month. No new metastatic lesions may appear. Stable disease is defined as: tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD) - increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 25% increase in area of disease involvement in the case of cutaneous disease) compared to the smallest previous measurements, or the development of any new metastatic or cutaneous disease.

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

Complete Response (CR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H4Not reportedNot reportedNot reportedNot reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H1Not reportedNot reportedNot reportedNot reported

Partial response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H0Not reportedNot reportedNot reportedNot reported

Progressive disease (PD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Transplant Therapy With Campath-1H0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      Complete Response (CR)
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Stable Disease
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Partial response (PR)
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Progressive disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Overall response following stem cell transplant. 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. Partial response (PR) - a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 50% reduction in area of disease involvement in the case of cutaneous disease) lasting for a period of at least one month. No new metastatic lesions may appear. Stable disease is defined as: tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD) - increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 25% increase in area of disease involvement in the case of cutaneous disease) compared to the smallest previous measurements, or the development of any new metastatic or cutaneous disease.
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
reporting Status
POSTED
time Frame
Up to 3 years
title
Overall Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice