Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03306264 · OUTCOME

AML: Percentage of Participants With CR With Partial Hematologic Recovery (CRh) Based on IWG 2003 AML Response Criteria

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 of Cycle 3 up to approximately 2.4 years (each cycle= 28 days)

What was measured

CRh was defined as \<5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets \>50,000/μL and ANC \>500/μL), independence from RBC and platelet transfusions within 7 days of bone marrow evaluation, and peripheral blast ≤1%. Percentage of participants with CRh based on IWG 2003 AML response criteria are reported.

Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment.

Groups in this outcome

AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727

Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727

Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

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

Analysis denominator · Participants

GroupSource count
AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX72743
AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX72744

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX7274.7Not reported0.615.8Not reported
AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX7270Not reported0.08.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        15.8
        value
        4.7
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        8.0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      44
    units
    Participants
description
CRh was defined as \<5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets \>50,000/μL and ANC \>500/μL), independence from RBC and platelet transfusions within 7 days of bone marrow evaluation, and peripheral blast ≤1%. Percentage of participants with CRh based on IWG 2003 AML response criteria are reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    OG000
    title
    AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
  2. description
    Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    OG001
    title
    AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
param Type
NUMBER
population Description
Efficacy Analysis Set included all participants who received any amount of study treatment.
reporting Status
POSTED
time Frame
Day 1 of Cycle 3 up to approximately 2.4 years (each cycle= 28 days)
title
AML: Percentage of Participants With CR With Partial Hematologic Recovery (CRh) Based on IWG 2003 AML Response Criteria
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice