A Phase 1 interventional study of imetelstat in High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation and Acute Myeloid Leukemia (AML), sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment
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).
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 27 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Unstable cardiovascular function as listed below:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive imetelstat intravenously every 4 weeks with dose escalation.
Drug: imetelstat
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.
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).
Time frame: 1 year
Incidence of adverse events
Adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Overall survival (OS)
OS is defined from the time of allo-SCT to the date of death from any cause.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2031, 48 months later.
Of 305 non-industry phase 1 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 87. This study's planned 48 months is close to that.
Counting every sponsor, half of 488 studies reached it within 49 months; a quarter within 31 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imetelstat
University of Wisconsin, Madison →