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NCT00719849 · OUTCOME

Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease · Source last updated 2017-06-14

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
Day 100 post transplant

What was measured

Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)

Groups in this outcome

Cyclophosphamide/Fludarabine/TBI

Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Cyclophosphamide/Fludarabine/TBI/ATG

Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 * Equine ATG 30mg/Kg Days -6 to -4 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

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

Analysis denominator · Participants

GroupSource count
Cyclophosphamide/Fludarabine/TBI4
Cyclophosphamide/Fludarabine/TBI/ATG8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide/Fludarabine/TBI3Not reportedNot reportedNot reportedNot reported
Cyclophosphamide/Fludarabine/TBI/ATG6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)
groups
  1. description
    Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
    id
    OG000
    title
    Cyclophosphamide/Fludarabine/TBI
  2. description
    Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 * Equine ATG 30mg/Kg Days -6 to -4 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
    id
    OG001
    title
    Cyclophosphamide/Fludarabine/TBI/ATG
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 100 post transplant
title
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice