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NCT01008462 · OUTCOME

Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease

Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia · Source last updated 2019-06-11

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-allograft,

What was measured

aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Analysis population: Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.

Groups in this outcome

Treatment (Autologous HCT, Donor HCT)

Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

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

Analysis denominator · Participants

GroupSource count
Treatment (Autologous HCT, Donor HCT)14

Reported measurements

Acute Graft-versus-Host-Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Autologous HCT, Donor HCT)8Not reportedNot reportedNot reportedNot reported
Chronic extensive Graft-versus-Host-Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Autologous HCT, Donor HCT)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Acute Graft-versus-Host-Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Chronic extensive Graft-versus-Host-Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
groups
  1. description
    Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    OG000
    title
    Treatment (Autologous HCT, Donor HCT)
param Type
COUNT_OF_PARTICIPANTS
population Description
Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.
reporting Status
POSTED
time Frame
1 year post-allograft,
title
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice