Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
← catalyst calendarSponsored by Geron Corporation (industry) · GERN — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
289actual
Sites
126
Countries
Belgium, Canada, Czechia +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2016-01-12 | actual | When the study began enrolling |
| Primary completion | 2023-10-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-13 | estimated | The whole study's end, after follow-up |
| First posted | 2015-11-06 | estimated | When this record first appeared on the registry |
| Results posted | 2025-02-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelodysplastic Syndromes
Interventions
- Drug: Imetelstat Sodium — also filed as GRN163L
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPhase 2: Percentage of Participants Without Any Red Blood Cell (RBC) Transfusion During Any Consecutive 8-Weeks Period (All Participants)
measured Up to 5 years in Phase 2
Phase 2: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period in Target Population
measured Up to 5 years in Phase 2
Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period
measured Up to 3.7 years in Phase 3
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-12-13 · 2.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-09-15 · 868 KB · SAP_001.pdf
Publications
- PMID 41568521 — linked by the registry
- PMID 41135032 — linked by the registry
- PMID 38048786 — linked by the registry
- PMID 33108243 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · GERN's whole pipeline · Catalyst calendar · Every registered study · What changed