Phase 2 Study Of Imetelstat for Patient With Myelodysplastic/Myeloproliferative Neoplasms
Starting soon · Phase 2
Conditions studied: Phase II, Imetelstat, Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
In brief
To learn if imetelstat can help to control MDS/MPNs.
Key facts
- Study ID
- NCT07549451
- Run by
- M.D. Anderson Cancer Center
- People needed
- 30
- Starts
- 2026-10-08
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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