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NCT05184842 · BASELINE

Baseline characteristics

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML · Source last updated 2026-01-05

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

denoms
  1. counts
    1. group Id
      BG000
      value
      31
    units
    Participants
groups
  1. description
    Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 28 of each cycle (28day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
    id
    BG000
    title
    Decitabine/Venetoclax (Single Arm)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          87
          value
          73
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62
          upper Limit
          83
          value
          75
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the Acute Myeloid Leukemia (AML) cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          87
          value
          61.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    6 of the 31 patients were part of the HR-MDS cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62
          upper Limit
          70
          value
          67.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the 'Other' cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    4 of the 31 patients were part of the 'Other' (non AML or non HR-MDS) cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      < 75 years old
    description
    The number/percentage of patients who are \< 75 years old and ≥75 years old at baseline is summarized.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the AML cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the HR-MDS cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 of the 31 patients were part of the HR-MDS cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the 'Other' (non AML or non HR-MDS) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    4 of the 31 patients were part of the 'Other' cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    description
    Sex (Female, Male) summarized for initial group of 31 patients who comprised the Primary Outcome Measure.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the Acute Myeloid Leukemia (AML) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients were part of the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the 'Other' cohort. This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    4 patients were part of the 'Other' cohort. This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline Analyses for initial group of 31 patients who comprised the Primary Outcome Measure.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    units
    Participants
groups
  1. description
    Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 28 of each cycle (28day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
    id
    BG000
    title
    Decitabine/Venetoclax (Single Arm)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          87
          value
          73
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62
          upper Limit
          83
          value
          75
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the Acute Myeloid Leukemia (AML) cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          87
          value
          61.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    6 of the 31 patients were part of the HR-MDS cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62
          upper Limit
          70
          value
          67.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
    description
    Age, Continuous data is summarized for patients in the 'Other' cohort.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    4 of the 31 patients were part of the 'Other' (non AML or non HR-MDS) cohort.
    title
    Age, Continuous
    unit Of Measure
    years
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      < 75 years old
    description
    The number/percentage of patients who are \< 75 years old and ≥75 years old at baseline is summarized.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the AML cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the HR-MDS cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 of the 31 patients were part of the HR-MDS cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      > 75 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      < 75 years old
    description
    Age, Customized data is summarized for patients in the 'Other' (non AML or non HR-MDS) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    4 of the 31 patients were part of the 'Other' cohort.
    title
    Age, Customized
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    description
    Sex (Female, Male) summarized for initial group of 31 patients who comprised the Primary Outcome Measure.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          21
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the Acute Myeloid Leukemia (AML) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    21 of the 31 patients were part of the AML cohort.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients were part of the higher risk Myelodysplastic Syndrome (HR-MDS) cohort.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
    description
    Sex (Female, Male) is summarized for patients in the 'Other' cohort. This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    4 patients were part of the 'Other' cohort. This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline Analyses for initial group of 31 patients who comprised the Primary Outcome Measure.

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Preserved source evidence · Not medical advice