NCT01789255 · OUTCOME

Median Plasma Concentration of IL-6 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: pg/mL
Interval / dispersion: Full Range
Time frame: Up to day 100

What was measured

Median plasma concentration of IL-6 (Interleukin-6 cytokine) was compared in patients treated with Vorinostat to those not treated with Vorinostat.

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

Group	Source count
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)	37

Reported measurements

Treated with Vorinostat

Values in pg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)	4.2	Not reported	0.1	22.3	Not reported

Not Treated with Vorinostat

Values in pg/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)	7.6	Not reported	0.3	70.1	Not reported

Source statistical analyses

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

group Ids
OG000
non Inferiority Type
OTHER
p Value
0.028
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Ids
OG000
non Inferiority Type
OTHER
p Value
0.028
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
lower Limit
0.1
upper Limit
22.3
value
4.2
title
Treated with Vorinostat
categories
measurements
group Id
OG000
lower Limit
0.3
upper Limit
70.1
value
7.6
title
Not Treated with Vorinostat

denoms

counts
group Id
OG000
value
37
units
Participants

description

Median plasma concentration of IL-6 (Interleukin-6 cytokine) was compared in patients treated with Vorinostat to those not treated with Vorinostat.

dispersion Type

Full Range

groups

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 Plasma Concentration of IL-6 in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat

type

SECONDARY

unit Of Measure

pg/mL

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

Preserved source evidence · Not medical advice