MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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secondary · POSTED

Clinical Activity Assessed by Change in Peripheral Blood Counts

Source null

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secondary · POSTED

Clinical Activity Assessed by Change in Transfusion Requirements

Due to the limited number of clinical responders, this outcome was not measured.

→

secondary · POSTED

Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)

Due to the limited number of clinical responders, the research assay was not done.

→

secondary · POSTED

Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry

Due to the limited number of clinical responders, the research assay was not done.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id: NCT00462605
trial label: MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0000
source section id
NCT00462605-om-0000
source outcome index
0
endpoint
Response (Complete and Partial Response) in Patients With Myeloid Disorders
endpoint definition
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.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0001
source section id
NCT00462605-om-0001
source outcome index
1
endpoint
Clinical Activity Assessed by Change in Peripheral Blood Counts
endpoint definition
Clinical Activity Assessed by Change in Peripheral Blood Counts
time origin
Baseline and after 2 cycles
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0002
source section id
NCT00462605-om-0002
source outcome index
2
endpoint
Clinical Activity Assessed by Change in Transfusion Requirements
endpoint definition
Clinical Activity Assessed by Change in Transfusion Requirements
time origin
Baseline and after 2 cycles
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Due to the limited number of clinical responders, this outcome was not measured.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0003
source section id
NCT00462605-om-0003
source outcome index
3
endpoint
Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)
endpoint definition
Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)
time origin
Baseline and 6, 12, 24, and 36 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Due to the limited number of clinical responders, the research assay was not done.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0004
source section id
NCT00462605-om-0004
source outcome index
4
endpoint
Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry
endpoint definition
Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry
time origin
Baseline and 6, 12, 24, and 36 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Due to the limited number of clinical responders, the research assay was not done.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0000
arm key
OG000
arm label
Arm I
regimen
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
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00462605-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
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
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00462605-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0002
arm key
OG000
arm label
Arm I
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00462605-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0003
arm key
OG000
arm label
Arm I
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00462605-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
outcome key
om-0004
arm key
OG000
arm label
Arm I
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00462605-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-kymriah-f0cd26fe
nct id
NCT00462605
harm key
EG000
source section id
NCT00462605-ae
event group key
EG000
event group label
Arm I
serious affected
19
serious at risk
24
other affected
6
other at risk
24
frequency threshold
4
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice