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NCT01044745 · OUTCOME

Event-free Survival

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
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From the date of transplant with relapse/progression or death as censored events, up to 2 years

What was measured

Estimated using Kaplan-Meier estimator.

Groups in this outcome

Treatment (Rituximab and Allogeneic HCT Transplant)

CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. 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: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy

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 months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Rituximab and Allogeneic HCT Transplant)12Not reported618Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        18
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Estimated using Kaplan-Meier estimator.
dispersion Type
Full Range
groups
  1. description
    CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. 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: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy
    id
    OG000
    title
    Treatment (Rituximab and Allogeneic HCT Transplant)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the date of transplant with relapse/progression or death as censored events, up to 2 years
title
Event-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice