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NCT01915498 · OUTCOME

Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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
Not reported
Time frame
Baseline to the end of treatment; overall median duration of treatment exposure in Phase 1 combined was 5.1 months (range 0.4, 34.2 months).

What was measured

Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 28 days before and 28 days after the first dose of treatment for Phase 1. Results are reported for all participants in Phase 1 combined and for the subset of participants with R/R AML.

Analysis population: The population included all participants who received at least one dose of study treatment in Phase 1 Dose Escalation and Dose Expansion. Results were analyzed and are reported for Phase 1 combined.

Groups in this outcome

Phase 1: Enasidenib - R/R AML

Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion with R/R AML who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1: Enasidenib

Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Enasidenib - R/R AML175
Phase 1: Enasidenib239

Reported measurements

Baseline Transfusion Dependent

Analysis denominator · Participants

GroupSource count
Phase 1: Enasidenib - R/R AML135
Phase 1: Enasidenib182
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Enasidenib - R/R AML39.3Not reportedNot reportedNot reportedNot reported
Phase 1: Enasidenib38.5Not reportedNot reportedNot reportedNot reported
Baseline Transfusion Independent

Analysis denominator · Participants

GroupSource count
Phase 1: Enasidenib - R/R AML40
Phase 1: Enasidenib57
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Enasidenib - R/R AML80.0Not reportedNot reportedNot reportedNot reported
Phase 1: Enasidenib71.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39.3
      2. group Id
        OG001
        value
        38.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        135
      2. group Id
        OG001
        value
        182
      units
      Participants
    title
    Baseline Transfusion Dependent
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        80.0
      2. group Id
        OG001
        value
        71.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    Baseline Transfusion Independent
denoms
  1. counts
    1. group Id
      OG000
      value
      175
    2. group Id
      OG001
      value
      239
    units
    Participants
description
Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 28 days before and 28 days after the first dose of treatment for Phase 1. Results are reported for all participants in Phase 1 combined and for the subset of participants with R/R AML.
groups
  1. description
    Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion with R/R AML who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 1: Enasidenib - R/R AML
  2. description
    Participants in Phase 1 Dose Escalation and Phase 1 Dose Expansion who received any dose of enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG001
    title
    Phase 1: Enasidenib
param Type
NUMBER
population Description
The population included all participants who received at least one dose of study treatment in Phase 1 Dose Escalation and Dose Expansion. Results were analyzed and are reported for Phase 1 combined.
reporting Status
POSTED
time Frame
Baseline to the end of treatment; overall median duration of treatment exposure in Phase 1 combined was 5.1 months (range 0.4, 34.2 months).
title
Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice