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NCT00506129 · OUTCOME

Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)

Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma · Source last updated 2020-12-29

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
Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.

What was measured

Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.

Groups in this outcome

Fludarabine + Melphalan With PBPC

Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

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

Analysis denominator · Participants

GroupSource count
Fludarabine + Melphalan With PBPC33

Reported measurements

Complete Response (CR) Converted Post Transplant
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine + Melphalan With PBPC19Not reportedNot reportedNot reportedNot reported
CR Prior to Transplant
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine + Melphalan With PBPC6Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine + Melphalan With PBPC0Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine + Melphalan With PBPC0Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine + Melphalan With PBPC16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Complete Response (CR) Converted Post Transplant
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    CR Prior to Transplant
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Stable Disease (SD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
groups
  1. description
    Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
    id
    OG000
    title
    Fludarabine + Melphalan With PBPC
param Type
NUMBER
reporting Status
POSTED
time Frame
Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
title
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice