NCT00462605 · OUTCOME

Response (Complete and Partial Response) in Patients With Myeloid Disorders

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 2 years

What was measured

Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.

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

Source class 1

Complete Remission (CR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported

Partial Remission (PR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1	Not reported	Not reported	Not reported	Not reported

Hematologic Improvement in Neutrophils (HI-N)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	2	Not reported	Not reported	Not reported	Not reported

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	5	Not reported	Not reported	Not reported	Not reported

Progressive Disease (PD)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
title
Complete Remission (CR)
measurements
group Id
OG000
value
1
title
Partial Remission (PR)
measurements
group Id
OG000
value
2
title
Hematologic Improvement in Neutrophils (HI-N)
measurements
group Id
OG000
value
5
title
Stable Disease (SD)
measurements
group Id
OG000
value
2
title
Progressive Disease (PD)

denoms

counts
group Id
OG000
value
10
units
Participants

description

Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.

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

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up to 2 years

title

Response (Complete and Partial Response) in Patients With Myeloid Disorders

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice