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NCT05282459 · OUTCOME

Clinical Response: Hematological Improvement - Erythroid (HI-E)

Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation · Source last updated 2026-09-03

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
16 weeks

What was measured

Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions

Groups in this outcome

Enasidenib Mesylat 100mg

Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.

Enasidenib Mesylat 200mg

Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.

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

Analysis denominator · Participants

GroupSource count
Enasidenib Mesylat 100mg2
Enasidenib Mesylat 200mg8

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enasidenib Mesylat 100mg0Not reportedNot reportedNot reportedNot reported
Enasidenib Mesylat 200mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
groups
  1. description
    Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
    id
    OG000
    title
    Enasidenib Mesylat 100mg
  2. description
    Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
    id
    OG001
    title
    Enasidenib Mesylat 200mg
param Type
NUMBER
reporting Status
POSTED
time Frame
16 weeks
title
Clinical Response: Hematological Improvement - Erythroid (HI-E)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice