High-risk Myeloid MalignancyPhase 1NCT07909733
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
A Phase 1 study testing imetelstat in people with High-risk Myeloid Malignancy and Allogenic Stem Cell Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation, Acute Myeloid Leukemia (AML)
- What is being tested?
- imetelstat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Feb 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Scoring System (IPSS-R) or moderate high, high and very high-risk MDS per Molecular International Prognostic Scoring System (IPSS-M)
- Chronic myeloid leukemia (CML) in accelerated phase or myeloid blast phase
Show all 13Show fewer
- Intermediate or high-risk primary myelofibrosis (PMF) by Dynamic International Prognostic Scoring System (DIPSS)-plus, Mutation-Enhanced International Prognostic Scoring System 70 (MIPSS-70)-plus version 2.0, or Myelofibrosis Secondary to Polycythemia Vera and Essential Thrombocythemia-Prognostic Model (MYSEC-PM) score
- Secondary myelofibrosis
- Primary myelofibrosis (PMF) in accelerated or blast phase
- Can be on immunosuppression drug(s)
- There is no morphologic evidence of disease relapse at the time of screening, and minimal residual disease (MRD) is acceptable.
- Karnofsky performance status of 60 or above or ECOG performance status <2.
- Able to sign informed consent
Who cannot join
- Participants with active acute graft-versus-host disease (GVHD) Grade II-IV. Participants with controlled acute GVHD <grade II on stable dose steroid <=0.5mg/kg prednisone could be considered after discussion with study PI.
- Participants with available post SCT maintenance therapy, such as FLT3-ITD mutated AML or CML with TKIs, will be excluded unless these treatments cannot be given.
- Treatment with any investigational agent within three weeks prior to first dose in this study. Concurrent donor lymphocyte infusion is not allowed while on the study. Participants on the study will be taken off the study in order to receive donor lymphocyte infusion.
- Unstable cardiovascular function as listed below:
- symptomatic ischemia
- uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded)
- congestive heart failure (CHF) NYHA Class ≥ 3
- myocardial infarction (MI) within 3 months Note: Cardiovascular function testing (including echocardiogram) done as part of SCT screening. Consider repeat cardiac testing as standard of care if clinically indicated • Any medical condition which, in the investigator's opinion, could compromise the participant's safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Cancer connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
Hongtao Liu, MD, PhD
About this study
Official title: UW26119: Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allogeneic Stem Cell Transplantation
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.
Read the detailed description
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).
- Conditions
- High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation, Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Primary Myelofibrosis (PMF), Intermediate-risk Myelodysplastic Syndrome
- Being tested
- imetelstat
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imetelstatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Participants will receive imetelstat intravenously every 4 weeks with dose escalation. Receives: Drug: imetelstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of imetelstat
MTD defined as the highest dose level at which < 2 of 6 subjects experience a dose- limiting toxicity (DLT).
Measured: 1 year
Secondary outcomes (5)
Incidence of adverse events
Adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: 2 years
Rate of non-relapse mortality (NRM)
NRM is defined as the duration between the date of allo-SCT and the date of patient death due to reasons other than relapse.
Measured: 2 years
Rate of relapse
Relapse is defined by the commonly used, well established criteria for each disease. For acute leukemia, relapse is defined by the reappearance of >5% myeloblasts in the BM not attributable to BM regeneration or to any other cause. For other conditions including myelofibrosis, CML, and MDS, relapse will be defined by hematologic, morphologic, cytogenetic, or molecular recurrence in the clinical setting that is pertinent for that disease.
Measured: 2 years
Progression-free survival (PFS)
PFS is defined from the time of allo-SCT to disease relapse or death from any cause.
Patients alive and progression free will be censored at the date of the last negative bone marrow.
Measured: 2 years
Overall survival (OS)
OS is defined from the time of allo-SCT to the date of death from any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Myeloid MalignancyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This clinical trial is divided into two parts: dose escalation (part A) and does expansion (part B). In part A, participants will be treated with imetelstat at different doses. The MTD decided as per part A will be used for part B.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Geron Corporation
- Responsible party
- Sponsor
- Investigators
- Hongtao Liu, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909733
- Sponsor's protocol ID
- 2026-1526
- Other IDs
- UW26119, UWMSN | SMPH | DOM Hematology, Protocol Version 9/28/2026
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW26119: Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07909733
- Acronym / sponsor ID
- 2026-1526
- Conditions
- High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation, Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Primary Myelofibrosis (PMF), Intermediate-risk Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Geron Corporation
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial is divided into two parts: dose escalation (part A) and does expansion (part B). In part A, participants will be treated with imetelstat at different doses. The MTD decided as per part A will be used for part B.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: imetelstatParticipants will receive imetelstat intravenously every 4 weeks with dose escalation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 Scoring System (IPSS-R) or moderate high, high and very high-risk MDS per Molecular International Prognostic Scoring System (IPSS-M)
Key exclusion criteria (8 listed)
- Participants with active acute graft-versus-host disease (GVHD) Grade II-IV. Participants with controlled acute GVHD <grade II on stable dose steroid <=0.5mg/kg prednisone could be considered after discussion with study PI.
- Participants with available post SCT maintenance therapy, such as FLT3-ITD mutated AML or CML with TKIs, will be excluded unless these treatments cannot be given.
- Treatment with any investigational agent within three weeks prior to first dose in this study. Concurrent donor lymphocyte infusion is not allowed while on the study. Participants on the study will be taken off the study in order to receive donor lymphocyte infusion.
- Unstable cardiovascular function as listed below:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imetelstatParticipants 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. | Drug | Dose escalation |
Primary outcome
Maximum tolerated dose (MTD) of imetelstat
Time frame: 1 year
MTD defined as the highest dose level at which < 2 of 6 subjects experience a dose- limiting toxicity (DLT).
5 secondary outcomes
Incidence of adverse events
Time frame: 2 years
Rate of non-relapse mortality (NRM)
Time frame: 2 years
Rate of relapse
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongtao Liu, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing imetelstat in people with High-risk Myeloid Malignancy and Allogenic Stem Cell Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of imetelstat (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.