Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02719574 · OUTCOME

Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)

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
MEDIAN
Unit
Months
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 82 months)

What was measured

RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.

Analysis population: Full analysis set (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 CR/CRi after prior therapy with residual 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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Cohort 2; FT-2102 (Single Agent)18.40Not reported9.50NASince the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
        group Id
        OG000
        lower Limit
        9.50
        upper Limit
        NA
        value
        18.40
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with AML in morphologic CR/CRi after prior therapy with residual 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
MEDIAN
population Description
Full analysis set (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 82 months)
title
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice