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NCT03734601 · OUTCOME

Graft vs Host Disease (GvHD)

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation · Source last updated 2023-12-12

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

What was measured

Recipients will be monitored for Grade 2 to 4 graft vs host disease (GvHD). The outcome is reported as the number of transplant recipients who experienced acute GvHD grades 2 to 4, the number of transplant recipients who experienced chronic and extensive GvHD. In addition, the number of transplant recipients with chronic and extensive GvHD that was refractory to treatment ("persistent") is reported. Per protocol, the result for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD.

Analysis population: Per protocol, the outcome for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD.

Groups in this outcome

TBI+TLI

TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days

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

Analysis denominator · Participants

GroupSource count
TBI+TLI22

Reported measurements

Acute GvHD

Analysis denominator · Participants

GroupSource count
TBI+TLI22
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBI+TLI5Not reportedNot reportedNot reportedNot reported
Chronic extensive GvHD

Analysis denominator · Participants

GroupSource count
TBI+TLI22
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBI+TLI8Not reportedNot reportedNot reportedNot reported
Chronic extensive and persistent GvHD

Analysis denominator · Participants

GroupSource count
TBI+TLI8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBI+TLI3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Acute GvHD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Chronic extensive GvHD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Chronic extensive and persistent GvHD
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Recipients will be monitored for Grade 2 to 4 graft vs host disease (GvHD). The outcome is reported as the number of transplant recipients who experienced acute GvHD grades 2 to 4, the number of transplant recipients who experienced chronic and extensive GvHD. In addition, the number of transplant recipients with chronic and extensive GvHD that was refractory to treatment ("persistent") is reported. Per protocol, the result for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD.
groups
  1. description
    TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days
    id
    OG000
    title
    TBI+TLI
param Type
COUNT_OF_PARTICIPANTS
population Description
Per protocol, the outcome for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD.
reporting Status
POSTED
time Frame
1 year
title
Graft vs Host Disease (GvHD)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice