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NCT05282459 · OUTCOME

Duration of 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
16 weeks

What was measured

Duration of Hematological Improvement - Erythroid (HI-E) will be assessed as the time from recorded response to loss of response. Participants will be 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 The outcome will be reported as the number of participants that achieve the response, a number without dispersion.

Analysis population: No participants achieved Hematological Improvement - Erythroid (HI-E), and therefore no results could be calculated.

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 100mg0
Enasidenib Mesylat 200mg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Duration of Hematological Improvement - Erythroid (HI-E) will be assessed as the time from recorded response to loss of response. Participants will be 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 The outcome will be reported as the number of participants that achieve the response, a number without dispersion.
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
population Description
No participants achieved Hematological Improvement - Erythroid (HI-E), and therefore no results could be calculated.
reporting Status
POSTED
time Frame
16 weeks
title
Duration of Hematological Improvement - Erythroid (HI-E)
type
SECONDARY

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

Preserved source evidence · Not medical advice