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NCT02598661 · OUTCOME

Phase 2 and Phase 3: Duration of Myeloid Growth Factors Administration

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

Duration of myeloid growth factor administered starting from Study Day 1 was reported.

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. Overall number of participants analyzed is the number of participants who had at least 1 dose of myeloid growth factors in Phase 2 and Phase 3.

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 Sodium19
Phase 3: Imetelstat Sodium42
Phase 3: Placebo3

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Imetelstat Sodium1.43Not reported0.1118.0Not reported
Phase 3: Imetelstat Sodium0.71Not reported0.112.9Not reported
Phase 3: Placebo3.14Not reported0.110.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        118.0
        value
        1.43
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        12.9
        value
        0.71
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        10.0
        value
        3.14
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      42
    3. group Id
      OG002
      value
      3
    units
    Participants
description
Duration of myeloid growth factor administered starting from Study Day 1 was reported.
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 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. Overall number of participants analyzed is the number of participants who had at least 1 dose of myeloid growth factors in Phase 2 and Phase 3.
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: Duration of Myeloid Growth Factors Administration
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice