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

NCT07549451 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-1970NCI-2026-03174
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if imetelstat can help to control MDS/MPNs.

Conditions

Phase II; Imetelstat; Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs).

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

  Through study completion; an average of 1 year

Study Arms (1)

SingleArm: Treatment with Imetelstat (IV) Q4W

EXPERIMENTAL

Drug: Imetelstat

Interventions

Imetelstat DRUG

Given by IV

SingleArm: Treatment with Imetelstat (IV) Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Geron Corporation: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Disease

Interventions

imetelstat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bravo G Montalban, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bravo G Montalban, MD

CONTACT

713-794-3604; gmontalban1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)