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NCT02598661 · OUTCOME

Phase 2 and Phase 3: Time to Progression to Acute Myeloid Leukemia (AML)

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) · Source last updated 2026-07-17

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
Up to 6.6 years in Phase 2 and up to 4 years in Phase 3

What was measured

Time to progression to AML was defined as the interval from Study Day 1 to the date of AML diagnosis. Participants who did not progress to AML and were still alive at the cutoff date for the analysis or who withdrew from the study (withdrawal of consent or lost to follow-up), data was censored at the date of the last disease evaluation.

Analysis population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.

Groups in this outcome

Phase 2: Imetelstat Sodium

Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.

Phase 3: Imetelstat Sodium

Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.

Phase 3: Placebo

Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.

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: Imetelstat Sodium57
Phase 3: Imetelstat Sodium118
Phase 3: Placebo60

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Imetelstat SodiumNANot reported41.36NAMedian and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
Phase 3: Imetelstat SodiumNANot reportedNANAMedian, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
Phase 3: PlaceboNANot reportedNANAMedian, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
        group Id
        OG000
        lower Limit
        41.36
        upper Limit
        NA
        value
        NA
      2. comment
        Median, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median, lower limit and upper limit of 95% CI were not estimable by Kaplan-Meir method due to low number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      118
    3. group Id
      OG002
      value
      60
    units
    Participants
description
Time to progression to AML was defined as the interval from Study Day 1 to the date of AML diagnosis. Participants who did not progress to AML and were still alive at the cutoff date for the analysis or who withdrew from the study (withdrawal of consent or lost to follow-up), data was censored at the date of the last disease evaluation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
    id
    OG000
    title
    Phase 2: Imetelstat Sodium
  2. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    OG001
    title
    Phase 3: Imetelstat Sodium
  3. description
    Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    OG002
    title
    Phase 3: Placebo
param Type
MEDIAN
population Description
Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.
reporting Status
POSTED
time Frame
Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
title
Phase 2 and Phase 3: Time to Progression to Acute Myeloid Leukemia (AML)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice