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NCT05184842 · FLOW

Participant flow

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.

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 subcutaneous (SQ) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
    id
    FG000
    title
    Decitabine/Venetoclax (Single Arm)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
31 patients were consented/enrolled and comprised the Primary Outcome Measure analysis. Enrollment in progress at the time of this submission. The Primary Outcome Measure has been met and Results are being reported for the 31 participants who comprised the Primary Outcome Measure.
recruitment Details
Between April 2022 and September 2023, 31 patients were enrolled. Nearly half of the patients were from diverse racial and ethnic backgrounds reflecting the demographics of an inner-city hospital in the Bronx, New York City.
Complete source fields
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 subcutaneous (SQ) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
    id
    FG000
    title
    Decitabine/Venetoclax (Single Arm)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
31 patients were consented/enrolled and comprised the Primary Outcome Measure analysis. Enrollment in progress at the time of this submission. The Primary Outcome Measure has been met and Results are being reported for the 31 participants who comprised the Primary Outcome Measure.
recruitment Details
Between April 2022 and September 2023, 31 patients were enrolled. Nearly half of the patients were from diverse racial and ethnic backgrounds reflecting the demographics of an inner-city hospital in the Bronx, New York City.

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

Preserved source evidence · Not medical advice