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NCT01915498 · OUTCOME

Phase 2 Dose Expansion: Complete Response Rate

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
95% Confidence Interval
Time frame
Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).

What was measured

Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML as assessed by the investigator. CR for AML: - Absolute neutrophil count (ANC) \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions

Analysis population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD 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 2: Enasidenib 100 mg QD105

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD20.0Not reported12.828.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.8
        upper Limit
        28.9
        value
        20.0
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML as assessed by the investigator. CR for AML: - Absolute neutrophil count (ANC) \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Enasidenib 100 mg QD
param Type
NUMBER
population Description
All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).
title
Phase 2 Dose Expansion: Complete Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice