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NCT02719574 · OUTCOME

Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation · Source last updated 2026-06-29

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
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)

What was measured

RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.

Analysis population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.

Groups in this outcome

Phase 2: Cohort 2; FT-2102 (Single Agent)

Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 (\[IDH1\]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

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: Cohort 2; FT-2102 (Single Agent)18

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Cohort 2; FT-2102 (Single Agent)83Not reported58.696.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.6
        upper Limit
        96.4
        value
        83
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 (\[IDH1\]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    OG000
    title
    Phase 2: Cohort 2; FT-2102 (Single Agent)
param Type
NUMBER
population Description
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.
reporting Status
POSTED
time Frame
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)
title
Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice