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NCT02259348 · OUTCOME

Incidence and Severity of Acute GvHD

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation · Source last updated 2017-05-30

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
100 days post transplantation

What was measured

The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.

Analysis population: Two of six participants did not experience any acute GvHD.

Groups in this outcome

Participants

Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.

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

Analysis denominator · Participants

GroupSource count
Participants6

Reported measurements

Grade I
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants0Not reportedNot reportedNot reportedNot reported
Grade II
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants0Not reportedNot reportedNot reportedNot reported
Grade III
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants3Not reportedNot reportedNot reportedNot reported
Grade IV
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade I
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade II
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade III
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade IV
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.
groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    OG000
    title
    Participants
param Type
NUMBER
population Description
Two of six participants did not experience any acute GvHD.
reporting Status
POSTED
time Frame
100 days post transplantation
title
Incidence and Severity of Acute GvHD
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice