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Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy

NCT05583552 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-12

Study results available
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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.

Conditions

Interventions

DRUG

Imetelstat sodium

Intravenous injection

Sponsors & Collaborators

  • Geron Corporation

    collaborator INDUSTRY

  • Universitätsklinikum Leipzig

    collaborator OTHER

  • Saint-Louis Hospital, Paris, France

    collaborator OTHER

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • Australasian Leukaemia and Lymphoma Group

    collaborator OTHER

  • Groupe Francophone des Myelodysplasies

    collaborator OTHER

  • German Myelodysplastic Syndrome Study Group

    collaborator OTHER

  • GCP-Service International West GmbH

    lead INDUSTRY

Principal Investigators

  • Uwe Platzbecker, MD · Universitätsklinikum Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2025-03-27
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Australia
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05583552 on ClinicalTrials.gov