NCT00462605 · OUTCOME

Clinical Activity Assessed by Change in Peripheral Blood Counts

MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia · Source last updated 2017-07-18

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

Measure: MEAN
Unit: cell/mm^3
Interval / dispersion: Standard Error
Time frame: Baseline and after 2 cycles

Groups in this outcome

Arm I

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC

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
Arm I	10

Reported measurements

ANC +/- SEM at baseline

Values in cell/mm^3 · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I	578	126	Not reported	Not reported	Not reported

ANC +/- SEM after 2 cycles

Values in cell/mm^3 · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I	1137	384	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
126
value
578
title
ANC +/- SEM at baseline
categories
measurements
group Id
OG000
spread
384
value
1137
title
ANC +/- SEM after 2 cycles

denoms

counts
group Id
OG000
value
10
units
Participants

dispersion Type

Standard Error

groups

description
Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC
id
OG000
title
Arm I

param Type

MEAN

reporting Status

POSTED

time Frame

Baseline and after 2 cycles

title

Clinical Activity Assessed by Change in Peripheral Blood Counts

type

SECONDARY

unit Of Measure

cell/mm^3

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

Preserved source evidence · Not medical advice