NCT02598661 · OUTCOME

Phase 2 and Phase 3: Time to the 24-Weeks RBC 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 24-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 24-weeks RBC TI period.

Analysis population: Phase 2: All Treated 24-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 24-week RBC TI. Phase 3: ITT 24-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 24-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

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

Group	Source count
Phase 2: Imetelstat Sodium	14
Phase 3: Imetelstat Sodium	33
Phase 3: Placebo	2

Reported measurements

Source class 1

Values in weeks · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Imetelstat Sodium	8.79	Not reported	3.3	100.6	Not reported
Phase 3: Imetelstat Sodium	8.43	Not reported	2.1	37.6	Not reported
Phase 3: Placebo	3.79	Not reported	0.3	7.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.3
upper Limit
100.6
value
8.79
group Id
OG001
lower Limit
2.1
upper Limit
37.6
value
8.43
group Id
OG002
lower Limit
0.3
upper Limit
7.3
value
3.79

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
33
group Id
OG002
value
2
units
Participants

description

Time to 24-week RBC TI was defined as the interval from Study Day 1 to the first day of the first 24-weeks RBC TI period.

dispersion Type

Full Range

groups

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
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
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 24-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 24-week RBC TI. Phase 3: ITT 24-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 24-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 24-Weeks RBC TI

type

SECONDARY

unit Of Measure

weeks

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

Preserved source evidence · Not medical advice