Health Trials

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

ConditionsRecurrent Chronic Myelomonocytic LeukemiaRefractory Chronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, Not Otherwise SpecifiedRecurrent Atypical Chronic Myeloid LeukemiaRecurrent Myelodysplastic/Myeloproliferative NeoplasmRefractory Myelodysplastic/Myeloproliferative Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age >= 18 years

History of World Health Organization (WHO)-defined diagnosis of proliferative CMML (WBC count >= 13,000/mm^3 at time of diagnosis), or MDS/MPN overlap neoplasm with WBC count >= 13,000/mm3 at time of diagnosis (atypical CML and MDS/MPN-NOS).

NOTE: Hydroxyurea or hypomethylating induced leukopenia does not preclude inclusion. Discussion of WBC < 13,000/mm^3 due to treatment at the time of preregistration must be discussed with the Sponsor/Principal Investigator

Relapsed/refractory following treatment with hydroxyurea; or at least 4 cycles of treatment with hypomethylating agents; or who are intolerant of treatment with either therapy. Note: Prior exposure to erythropoiesis stimulating agents is allowed. Hydroxyurea may continue for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the Sponsor/Principal Investigator

Disqualifiers

Previous exposure to an alternative (investigational) PLK1 inhibitor

Demonstration of transformation to acute leukemia on any prior bone marrow biopsy

Prior allogeneic hematopoietic stem cell transplantation with active grade 2-4 graft-versus-host disease (GVHD) or with moderate to severe chronic GVHD

NOTE: The patient should not have received calcineurin inhibitors ≤28 days prior to pre-registration and should not be actively receiving immunosuppressive therapy for acute or chronic GVHD.

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration and Biopsy
  • Onvansertib
  • Ultrasound Imaging

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov