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NCT05184842 · OUTCOME

Measurable Residual Disease (MRD) in AML Patients Analyzed by ITT-PP

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At the time of censoring of data, up to ~21 months

What was measured

The number/percentage of AML patients analyzed by ITT-PP who achieved Measurable Residual Disease (MRD) negativity was determined by multiparameter flow cytometry (MFC). Achieving MRD negativity after achieving remission in a cancer treatment is associated is associated with longer remissions, potentially longer survival rates, and a lower risk of relapse.

Analysis population: 21 patients who comprised the Primary Outcome analysis were part of the AML cohort. Results for 2 of the 21 patients were not evaluable by ITT-PP analysis.

Groups in this outcome

Decitabine/Venetoclax (Single Arm)

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 22 of each cycle (28-day 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)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Decitabine/Venetoclax (Single Arm)19

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine/Venetoclax (Single Arm)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
The number/percentage of AML patients analyzed by ITT-PP who achieved Measurable Residual Disease (MRD) negativity was determined by multiparameter flow cytometry (MFC). Achieving MRD negativity after achieving remission in a cancer treatment is associated is associated with longer remissions, potentially longer survival rates, and a lower risk of relapse.
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 22 of each cycle (28-day 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
    OG000
    title
    Decitabine/Venetoclax (Single Arm)
param Type
COUNT_OF_PARTICIPANTS
population Description
21 patients who comprised the Primary Outcome analysis were part of the AML cohort. Results for 2 of the 21 patients were not evaluable by ITT-PP analysis.
reporting Status
POSTED
time Frame
At the time of censoring of data, up to ~21 months
title
Measurable Residual Disease (MRD) in AML Patients Analyzed by ITT-PP
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice