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NCT05379166 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome
A Phase 2 study of Therapy-Related Myelodysplastic Syndrome and Secondary Myelodysplastic Syndrome, sponsored by Uma Borate.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 3
- Study locations
NCT05379166: Active Phase 2 study of Therapy-Related Myelodysplastic Syndrome and Secondary Myelodysplastic Syndrome, sponsored by Uma Borate.
NCT05379166 is a Phase 2 study of Therapy-Related Myelodysplastic Syndrome and Secondary Myelodysplastic Syndrome that is active but no longer recruiting, run by Uma Borate. The registered enrollment target is 33 participants, below the 81-participant average among 4 other Therapy-Related Myelodysplastic Syndrome trials with a reported enrollment target (59% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05379166, a Phase 2 study of Therapy-Related Myelodysplastic Syndrome and Secondary Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Uma Borate.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the effect of venetoclax and azacitidine in treating patients with therapy related or secondary myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax in combination with azacitidine may work better in treating patients with therapy related or secondary myelodysplastic syndrome.
Primary Outcome
Defined by 2023 International Working Group (IWG) criteria. A point estimate and 95% exact (i.e., Clopper-Pearson) confidence interval will be computed for the CR rate within the efficacy-evaluable population.
Conditions Studied
Interventions
- DRUG Venetoclax
- OTHER Quality-of-Life Assessment
- DRUG Azacitidine
- OTHER Questionnaire Administration
Study Locations (3)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oregon
- Oregon Health & Science University - Portland
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 2 |
What the registry record for NCT05379166 still lists
NCT05379166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 81-participant average among 4 other Therapy-Related Myelodysplastic Syndrome trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Therapy-Related Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT05379166 reports a single indexed study location in Ohio, Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT05379166 about?
NCT05379166 is a clinical study titled "Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome". This phase II trial studies the effect of venetoclax and azacitidine in treating patients with therapy related or secondary myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, ...
What is the current status of trial NCT05379166?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2022-06-23. Estimated completion is 2026-04-15.
What conditions does trial NCT05379166 study?
This clinical trial studies the following conditions: Therapy-Related Myelodysplastic Syndrome, Secondary Myelodysplastic Syndrome.
What interventions are being tested in trial NCT05379166?
The interventions under investigation include: Venetoclax (DRUG), Quality-of-Life Assessment (OTHER), Azacitidine (DRUG), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT05379166?
This trial is sponsored by Uma Borate, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05379166 being conducted?
This trial has 3 study locations across Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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