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NCT01044745 · OUTCOME

Number of Participants With Grades II-IV Acute GVHD

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

Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.

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)20

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Rituximab and Allogeneic HCT Transplant)16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At day 100
title
Number of Participants With Grades II-IV Acute GVHD
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice