OncoMatch/Clinical Trials/NCT05549661
Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms
Is NCT05549661 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Onvansertib for recurrent chronic myelomonocytic leukemia.
Treatment: Onvansertib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hydroxyurea
Relapsed/refractory following treatment with hydroxyurea
Must have received: hypomethylating agent
at least 4 cycles of treatment with hypomethylating agents
Cannot have received: PLK1 inhibitor
Previous exposure to an alternative (investigational) PLK1 inhibitor
Cannot have received: allogeneic hematopoietic stem cell transplantation with active grade 2-4 GVHD or moderate to severe chronic GVHD
Exception: relapse after allogeneic stem cell transplant is allowed as long as >100 days after transplant and no active GVHD
Prior allogeneic hematopoietic stem cell transplantation with active grade 2-4 graft-versus-host disease (GVHD) or with moderate to severe chronic GVHD
Lab requirements
Blood counts
Platelet count >= 20,000/mm^3 (exceptions for disease-related thrombocytopenia with transfusional support)
Kidney function
eGFR >= 50 mL/min/m^2 by CKDEPI 2021, corrected creatinine clearance, or iothalamate/iohexol GFR
Liver function
Total bilirubin <= 1.5 x ULN (<= 3 x ULN for patients with Gilbert's syndrome); ALT and AST <= 3 x ULN
Cardiac function
QTcF <= 470 ms (<= 480 ms for TdP risk); NYHA class III/IV heart failure or active angina/angina equivalents excluded
Platelet count >= 20,000/mm^3; Total bilirubin <= 1.5 x ULN (<= 3 x ULN for Gilbert's syndrome); ALT and AST <= 3 x ULN; eGFR >= 50 mL/min/m^2; QTcF <= 470 ms; NYHA class III/IV heart failure or active angina/angina equivalents excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05549661 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PLK1 inhibitor, allogeneic hematopoietic stem cell transplantation with active grade 2-4 GVHD or moderate to severe chronic GVHD disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify