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NCT02598661 · OUTCOME

Phase 2 and Phase 3: Time to the 8-Weeks RBC Transfusion Independence (TI)

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
weeks
Interval / dispersion
Full Range
Time frame
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3

What was measured

Time to 8-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 8-week RBC TI period.

Analysis population: Phase 2: All Treated 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.

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 Sodium21
Phase 3: Imetelstat Sodium47
Phase 3: Placebo9

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Imetelstat Sodium8.29Not reported0.1100.6Not reported
Phase 3: Imetelstat Sodium9.29Not reported0.164.7Not reported
Phase 3: Placebo8.29Not reported0.146.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        100.6
        value
        8.29
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        64.7
        value
        9.29
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        46.9
        value
        8.29
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      47
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Time to 8-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 8-week RBC TI period.
dispersion Type
Full Range
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 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.
reporting Status
POSTED
time Frame
Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
title
Phase 2 and Phase 3: Time to the 8-Weeks RBC Transfusion Independence (TI)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice