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NCT01789255 · OUTCOME

The Percentage of Patients Alive Without GVHD or Use of Steroids

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies · Source last updated 2018-07-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

The percentage of patients alive without GVHD or use of steroids at 1 year.

Analysis population: This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.

Groups in this outcome

Supportive Care (Vorinostat, Tacrolimus, Methotrexate)

Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.

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

Analysis denominator · Participants

GroupSource count
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)37

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)47Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
The percentage of patients alive without GVHD or use of steroids at 1 year.
groups
  1. description
    Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
    id
    OG000
    title
    Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
param Type
NUMBER
population Description
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
reporting Status
POSTED
time Frame
Up to 1 year
title
The Percentage of Patients Alive Without GVHD or Use of Steroids
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice