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NCT05282459 · OUTCOME

Clinical Response: Hematological Improvement - Platelets (HI-P)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
8 weeks

What was measured

Clinical response for platelets was assessed as the number of participants achieving a hematological improvement - platelets (HI-P). Participants will be characterized and stratified as platelets \< or ≥ 20 x 10\^9/L, with response defined as follows. * \< 20 x 10\^9/L = increase in platelets from \< 20 x 10\^9/L to \> 20 x 10\^9/L AND by ≥ 100% * ≥ 20 x 10\^9/L = absolute increase in platelets of 30 x 10\^9/L The outcome will be reported as the number of participants that achieve the response, a number without dispersion.

Groups in this outcome

Enasidenib Mesylat 100 mg

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

Enasidenib Mesylat 200 mg

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 100 mg2
Enasidenib Mesylat 200 mg8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enasidenib Mesylat 100 mg0Not reportedNot reportedNot reportedNot reported
Enasidenib Mesylat 200 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Clinical response for platelets was assessed as the number of participants achieving a hematological improvement - platelets (HI-P). Participants will be characterized and stratified as platelets \< or ≥ 20 x 10\^9/L, with response defined as follows. * \< 20 x 10\^9/L = increase in platelets from \< 20 x 10\^9/L to \> 20 x 10\^9/L AND by ≥ 100% * ≥ 20 x 10\^9/L = absolute increase in platelets of 30 x 10\^9/L 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 100 mg
  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 200 mg
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
8 weeks
title
Clinical Response: Hematological Improvement - Platelets (HI-P)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice