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

Study acronym: IMpress
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Jun 2026 to Sep 30, 2025
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 1 of 11 sites
  2. Results first posted: May 12, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoint revised
    v18
  3. Primary completion date changed from estimate of Sep 30, 2025 to Mar 27, 2025
    • Secondary endpoints expanded, about 6 words
    • Primary endpoint revised
    v17
  4. Primary completion date: Feb 2025 to Sep 30, 2025v16
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Interventions: Imetelstat (Drug) to Imetelstat sodium (Drug)
    • Eligibility criteria expanded, about 25 words
    v14
  2. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 23 to 46
    • Site details revised at 11 of 11 sites
    v13
  3. Study sites: 12 to 11v12
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 46 to confirmed 23
    • Site details revised at 12 of 12 sites
    v11
  5. Primary completion date: Jan 2024 to Feb 2025v10
  6. Site details revised at 2 of 12 sitesv9
  7. Site details revised at 1 of 12 sitesv8
  8. Site details revised at 4 of 12 sitesv7
  9. Site details revised at 2 of 12 sitesv6
  10. Site details revised at 1 of 12 sitesv5
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2023 to Jun 5, 2023
    • Site details revised at 12 of 12 sites
    v4
  12. Re-verified, no change to tracked fieldsv3
  13. Start date: Dec 2022 to May 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05583552
Lead Sponsor GCP-Service International West GmbH
Collaborators: Geron 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
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov