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NCT01789255 · OUTCOME

Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat

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
MEDIAN
Unit
Ratio
Interval / dispersion
Full Range
Time frame
Up to day 100

What was measured

Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.

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

Treated with Vorinostat
Values in Ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)0.943Not reported0.421.27Not reported
Not Treated with Vorinostat
Values in Ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)0.679Not reported0.191.01Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.02642
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.02642
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.42
        upper Limit
        1.27
        value
        0.943
    title
    Treated with Vorinostat
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        1.01
        value
        0.679
    title
    Not Treated with Vorinostat
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.
dispersion Type
Full Range
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
MEDIAN
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 day 100
title
Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat
type
SECONDARY
unit Of Measure
Ratio

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

Preserved source evidence · Not medical advice