Phase 2 Imetelstat for Myelodysplastic/Myeloproliferative Neoplasms

This study is testing a drug called imetelstat for people with Myelodysplastic Syndromes (MDS) or Myeloproliferative Neoplasms (MPN). Researchers want to see if imetelstat is safe and how well it works to control these conditions. You might be able to join if you are 18 or older and have a specific type of MDS/MPN, such as CMML-1 or CMML-2, and have not responded well to other treatments like hydroxyurea, azacitidine, or decitabine. The study will look at side effects and how many people respond to the treatment. The goal is to see if imetelstat can lead to improvements in your condition.

Study design
This is a Phase 2 study, meaning it's an early-stage study to test safety and effectiveness. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

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NCT07549451

Phase 2 Study Of Imetelstat for Patient With Myelodysplastic/Myeloproliferative Neoplasms

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Imetelstat

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs).
Measured over Through study completion; an average of 1 year
Phase II
Imetelstat
Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
1 sites across 1 states
Texas1
  • Bravo G Montalban, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Exclusion

Participants who are currently receiving treatment for a malignancy (not including basal cell carcinoma,nonmelanoma skin cancer, cervical carcinoma in situ, early-stage breast cancer or localized prostate cancer treated with hormone therapy). Participants with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.
Participants who are receiving any other investigational agents within 7 days of C1D1 or who have received prior imetelstat therapy.
Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.
Platelet count \<50x109/L prior to enrollment and treatment initiation except if related to either recent treatment for MDS/MPN or treatment with cytotoxic therapy for any other reason.
Pregnant women are excluded from this study because imetelstat has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.
Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \[birth control pills\], contraceptive injections, intrauterine devices \[IUD\], double-barrier method \[spermicidal jelly or foam with condoms or diaphragm\], contraceptive patch, or surgical sterilization) throughout the study.
Female Participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy within 7 days of therapy initiation.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Safety and adverse events (AEs).Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0