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← Myelodysplastic/Myeloproliferative Neoplasms

NCT00067808 · STUDY IN CONTEXT

Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

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

Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to \>100 x 109/L; and 'No Response'.

As treated: 124 patients completed treatment.

→

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
NCT00067808
trial label
Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    outcome key
    om-0000
    source section id
    NCT00067808-om-0000
    source outcome index
    0
    endpoint
    Participant Responses
    endpoint definition
    Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to \>100 x 109/L; and 'No Response'.
    time origin
    Response to treatment after 8 weeks of therapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    As treated: 124 patients completed treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Decitabine 10 mg/m2 IV
    regimen
    10 mg/m2 by vein (IV) over 1 hour daily for 10 days
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00067808-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Decitabine 20 mg/m2 IV
    regimen
    20 mg/m2 IV over 1 hour daily for 5 days
    analyzed count
    93
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00067808-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Decitabine 20 mg/m2 SQ
    regimen
    20 mg/m2 subcutaneous (SQ) daily for 5 days
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00067808-om-0000#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    harm key
    EG000
    source section id
    NCT00067808-ae
    event group key
    EG000
    event group label
    Decitabine 10 mg/m2 IV
    serious affected
    5
    serious at risk
    17
    other affected
    4
    other at risk
    17
    frequency threshold
    0
    collection period
    6 Years
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    harm key
    EG001
    source section id
    NCT00067808-ae
    event group key
    EG001
    event group label
    Decitabine 20 mg/m2 IV
    serious affected
    32
    serious at risk
    93
    other affected
    32
    other at risk
    93
    frequency threshold
    0
    collection period
    6 Years
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00067808
    harm key
    EG002
    source section id
    NCT00067808-ae
    event group key
    EG002
    event group label
    Decitabine 20 mg/m2 SQ
    serious affected
    7
    serious at risk
    14
    other affected
    8
    other at risk
    14
    frequency threshold
    0
    collection period
    6 Years
    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