CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 46 enrolled
Drug / intervention
Imetelstat sodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05583552
NCT05583552Phase 2Active
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A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy

GCP-Service International West GmbH·interventional·Posted Oct 17, 2022·Updated May 12, 2026

In Brief

A Phase 2 clinical trial evaluating Imetelstat sodium for Myelodysplastic Syndromes and Acute Myeloid Leukemia. Active but no longer recruiting, targeting 46 participants across 11 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is relapsed/refractory to hypomethylating agents (HMAs) treatment. Responding patients are eligible to continue treatment until loss of response/disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes, Acute Myeloid Leukemia
CountriesAustralia, France, Germany
CollaboratorsGeron Corporation, Universitätsklinikum Leipzig, Saint-Louis Hospital, Paris, France, QIMR Berghofer Medical Research Institute, Australasian Leukaemia and Lymphoma Group, Groupe Francophone des Myelodysplasies, German Myelodysplastic Syndrome Study Group

Timeline

Phase 2ActiveOverdue
2023202420252026
First PostedOct 17, 2022
Enrollment StartJun 5, 2023
Primary CompletionMar 27, 2025
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.7 years ago

Interventions

Imetelstat sodiumdrug

Intravenous injection