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NCT00984165 · OUTCOME

Response to Graft Versus Host Disease (GVHD) Treatment

Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation · Source last updated 2018-05-02

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
Up to 100 days

What was measured

The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \>/= 70%). Non-responder (NR) \<50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \</= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.

Analysis population: No results were collected on the Donor Lymphocyte Infusion-Donor "Arm". This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group.

Groups in this outcome

Donor Lymphocyte Infusion/Radiation

Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).

Radiation/No Donor Lymphocyte Infusion

Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).

Donor Lymphocyte Infusion-Control

Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.

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

Analysis denominator · Participants

GroupSource count
Donor Lymphocyte Infusion/Radiation9
Radiation/No Donor Lymphocyte Infusion1
Donor Lymphocyte Infusion-Control4

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Donor Lymphocyte Infusion/Radiation0Not reportedNot reportedNot reportedNot reported
Radiation/No Donor Lymphocyte Infusion0Not reportedNot reportedNot reportedNot reported
Donor Lymphocyte Infusion-Control0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Donor Lymphocyte Infusion/Radiation1Not reportedNot reportedNot reportedNot reported
Radiation/No Donor Lymphocyte Infusion0Not reportedNot reportedNot reportedNot reported
Donor Lymphocyte Infusion-Control0Not reportedNot reportedNot reportedNot reported
Non-responder (NR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Donor Lymphocyte Infusion/Radiation6Not reportedNot reportedNot reportedNot reported
Radiation/No Donor Lymphocyte Infusion1Not reportedNot reportedNot reportedNot reported
Donor Lymphocyte Infusion-Control3Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Donor Lymphocyte Infusion/Radiation2Not reportedNot reportedNot reportedNot reported
Radiation/No Donor Lymphocyte Infusion0Not reportedNot reportedNot reportedNot reported
Donor Lymphocyte Infusion-Control1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Non-responder (NR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      4
    units
    Participants
description
The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \>/= 70%). Non-responder (NR) \<50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score \</= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.
groups
  1. description
    Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
    id
    OG000
    title
    Donor Lymphocyte Infusion/Radiation
  2. description
    Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
    id
    OG001
    title
    Radiation/No Donor Lymphocyte Infusion
  3. description
    Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
    id
    OG002
    title
    Donor Lymphocyte Infusion-Control
param Type
NUMBER
population Description
No results were collected on the Donor Lymphocyte Infusion-Donor "Arm". This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group.
reporting Status
POSTED
time Frame
Up to 100 days
title
Response to Graft Versus Host Disease (GVHD) Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice