Trials / Active Not Recruiting
Active Not RecruitingNCT05583552
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- GCP-Service International West GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Imetelstat sodium | Intravenous injection |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2025-09-30
- Completion
- 2026-06-01
- First posted
- 2022-10-17
- Last updated
- 2025-03-14
Locations
11 sites across 3 countries: Australia, France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05583552. Inclusion in this directory is not an endorsement.