RecruitingPhase 1NCT05549661

Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms

Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) and Myelodysplastic Syndrome/MPN Overlap Neoplasms Relapsed/Refractory or Intolerant to Available Therapies

Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Apr 4, 2023

Study Type

INTERVENTIONAL

Conditions

Recurrent Chronic Myelomonocytic Leukemia Refractory Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic/Myeloproliferative Neoplasm Refractory Myelodysplastic/Myeloproliferative Neoplasm Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified Recurrent Atypical Chronic Myeloid Leukemia

Summary

This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia and Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called onvansertib for people with chronic myelomonocytic leukemia (CMML) or related blood cancers that have come back or stopped responding to standard treatments like hydroxyurea or hypomethylating agents. **You may be eligible if...** - You are 18 or older - You have been diagnosed with proliferative CMML or a related blood cancer (atypical CML or MDS/MPN overlap) - Your cancer has relapsed or is refractory after treatment with standard drugs - You are in reasonably good physical condition **You may NOT be eligible if...** - You have a different type of leukemia (such as AML) - You have had a stem cell transplant recently - You have active uncontrolled infection - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUGOnvansertib

Given PO

PROCEDUREUltrasound Imaging

Undergo ultrasound imaging

Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05549661

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