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 (May 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
Cancer type
Acute Myeloid Leukemia
Myeloproliferative Neoplasm
Chronic Myeloid Leukemia
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
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