Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.

Treated population (16 patients); No further analysis done since study terminated early due to low accrual.

→

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-myelodysplastic-myeloproliferative-neoplasms
nct id: NCT00113321
trial label: Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 1
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-myeloproliferative-neoplasms
nct id
NCT00113321
outcome key
om-0000
source section id
NCT00113321-om-0000
source outcome index
0
endpoint
Overall Response
endpoint definition
Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.
time origin
Blood tests baseline and after completing 8-12 weeks of therapy
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated population (16 patients); No further analysis done since study terminated early due to low accrual.
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-myelodysplastic-myeloproliferative-neoplasms
nct id
NCT00113321
outcome key
om-0000
arm key
OG000
arm label
Decitabine
regimen
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00113321-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-myeloproliferative-neoplasms
nct id
NCT00113321
harm key
EG000
source section id
NCT00113321-ae
event group key
EG000
event group label
Decitabine
serious affected
6
serious at risk
16
other affected
13
other at risk
16
frequency threshold
5
collection period
2 years 1 month
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