drugset / Trial / NCT05583552
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
Phase 2
Active not recruiting
46 enrolled
GCP-Service International West GmbH
Australasian Leukaemia and Lymphoma Group · collabGerman Myelodysplastic Syndrome Study Group · collabGeron Corporation · collabGroupe Francophone des Myelodysplasies · collabQIMR Berghofer Medical Research Institute · collabSaint-Louis Hospital, Paris, France · collabUniversitätsklinikum Leipzig · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-06-05
- Primary completion
- 2025-03-27
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imetelstat | Oligonucleotide (other) | — | Intravenous |