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NCT01044745 · OUTCOME

Transplant-related Mortality (TRM)

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2023-09-06

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
At day 100

What was measured

Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.

Groups in this outcome

Treatment (Rituximab and Allogeneic HCT Transplant)

CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. rituximab: Given IV mycophenolate mofetil: Given IV or PO tacrolimus: Given IV anti-thymocyte globulin: Given IV allogeneic hematopoietic stem cell transplantation laboratory biomarker analysis: Correlative studies graft versus host disease prophyla

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 (Rituximab and Allogeneic HCT Transplant)18

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Rituximab and Allogeneic HCT Transplant)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. rituximab: Given IV mycophenolate mofetil: Given IV or PO tacrolimus: Given IV anti-thymocyte globulin: Given IV allogeneic hematopoietic stem cell transplantation laboratory biomarker analysis: Correlative studies graft versus host disease prophyla
    id
    OG000
    title
    Treatment (Rituximab and Allogeneic HCT Transplant)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At day 100
title
Transplant-related Mortality (TRM)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice