University of Wisconsin, Madison
The purpose of this clinical trial is to learn if imetelstat is safe to use in participants with high-risk myeloid malignancies who have received an allogenic hematologic stem cell transplantation (allo-SCT). Participants will receive imetelstat by intravenous infusion once every 28 days for up to one year.
This is an open-label, dose-escalation Phase I study with expansion cohort to evaluate the tolerability and efficacy of single-agent imetelstat as maintenance treatment to prevent relapse in patients with high-risk myeloid diseases after allogeneic stem cell transplantation (allo-SCT).
Inclusion Criteria: * Age 18 - 80 years at the time of consent * Participants with high-risk myeloid diseases after allo-SCT, including but not limited to the following: * Intermediate- or high-risk acute myeloid leukemia ( AML) per European Leukemia Net (ELN) 2022 or ELN 2024 criteria * Participants with myeloid malignancies that are minimal residual disease (MRD) positive by flow cytometry or other MRD tests; or with active disease (not in complete remission \[CR\]) prior to allo-SCT * Intermediate, high- or very high-risk myelodysplastic syndromes (MDS) per Revised International Prognostic…
Participants will receive imetelstat intravenously every 4 weeks with dose escalation from 3.5 mg/kg, 5.6 mg/kg and 7.1 mg/kg for up to 12 cycles. This study is an open label, Phase I dose escalation trial with an expansion cohort. The study consists of two parts: * Part A: Dose escalation. 9-12 participants will be enrolled in part A. * Part B: Dose expansion phase. 10-15 more participants will be enrolled in the dose-expansion cohort and will receive the MTD per part A.
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