Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00719849 · OUTCOME

Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year

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
1 year post transplant

What was measured

Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD 1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD. 2. Mild liver test abnormalities (alkaline phosphatase \<2 x upper limit of normal, AST or ALT \<3 x upper limit of normal and total bilirubin \<1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD. 3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving \<20% of body surface area (BSA), dyspigmentation involving \<20% BSA, or erythema involving \<50% BSA, positive skin biopsy, and no other manifestations of cGVHD. 4. Ocular sicca (Schirmer's test \<5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD. 5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.

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/TBI0Not reportedNot reportedNot reportedNot reported
Cyclophosphamide/Fludarabine/TBI/ATG3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD 1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD. 2. Mild liver test abnormalities (alkaline phosphatase \<2 x upper limit of normal, AST or ALT \<3 x upper limit of normal and total bilirubin \<1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD. 3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving \<20% of body surface area (BSA), dyspigmentation involving \<20% BSA, or erythema involving \<50% BSA, positive skin biopsy, and no other manifestations of cGVHD. 4. Ocular sicca (Schirmer's test \<5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD. 5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.
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
1 year post transplant
title
Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice