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NCT05549661 · ClinicalTrials.gov registry record · Phase 1
Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms
A Phase 1 study of Recurrent Chronic Myelomonocytic Leukemia and Refractory Chronic Myelomonocytic Leukemia, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05549661: Recruiting Phase 1 study of Recurrent Chronic Myelomonocytic Leukemia and Refractory Chronic Myelomonocytic Leukemia, sponsored by Mayo Clinic.
NCT05549661 is a Phase 1 study of Recurrent Chronic Myelomonocytic Leukemia and Refractory Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 62-participant average among 10 other Recurrent Chronic Myelomonocytic Leukemia trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05549661, a Phase 1 study of Recurrent Chronic Myelomonocytic Leukemia and Refractory Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Safety will be assessed primarily based on reported adverse events (AEs). The severity of AEs will be graded as mild, moderate, severe, or life-threatening according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All reported toxicities, regardless of attribution, will be summarized by toxicity type and maximum grade, and sorted by number of patients experiencing the toxicity. The maximum grade consolidates the reports of a given toxicity for a p
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Ultrasound Imaging
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Onvansertib
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT05549661 shows while recruiting
NCT05549661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 62-participant average among 10 other Recurrent Chronic Myelomonocytic Leukemia trials with a reported enrollment target (60% lower).
The record links to 6 conditions, with Recurrent Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05549661 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05549661 about?
NCT05549661 is a clinical study titled "Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms". 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 trea...
What is the current status of trial NCT05549661?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-04-04. Estimated completion is 2027-12-01.
What conditions does trial NCT05549661 study?
This clinical trial studies the following conditions: Recurrent Chronic Myelomonocytic Leukemia, Refractory Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified.
What interventions are being tested in trial NCT05549661?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Ultrasound Imaging (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Onvansertib (DRUG).
Who is sponsoring clinical trial NCT05549661?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05549661 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05549661's enrollment target sits among peer trials
25 11th of 10 the lowest of 10 other Recurrent Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Chronic Myelomonocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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