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NCT05148234 · ClinicalTrials.gov registry record · Phase 1
BMS-986253 in Myelodysplastic Syndromes
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT05148234: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT05148234 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05148234, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: The myelodysplastic syndromes (MDS) are a group of bone marrow neoplasms. MDS mostly affect elderly people. The drugs used to treat MDS are not always effective, and the only curative treatment is stem cell transplant. Researchers want to see if a new drug can be used to treat MDS. Objective: To learn if HuMax-interleukin 8 (IL-8) BMS-986253 is a safe and effective treatment for MDS. Eligibility: Adults aged 18 and older with MDS. Design: Participants will be screened with a medical history, medication review, and physical exam. They will answer questions about how well they are able to take care of themselves. Their temperature, blood pressure, breathing rate, and heart rate will be monitored. They will have an electrocardiogram to see how well their heart is working. They will give blood and urine samples. They may have a bone marrow biopsy. Participants will be assigned to a specific group. They will receive either BMS-986253 alone or in combination with deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi). Treatment will be given in 28-day cycles. Participants will get BMS-986253 as an infusion on days 1 and 15 of each cycle. Some participants also will take oral DNMTi on days 2-6 of each cycle. They will receive treatment until their disease gets worse or they have bad side effects. At study visits, some screening tests will be repeated. Some of the samples that are collected will be used for genetic testing. About 30 days after treatment ends, participants will have a follow-up visit to see how they are doing. After that, follow up will occur via phone every 3-6 months until the study ends. National Institutes of Health (NIH) will cover the costs for some travel expenses....
Interventions
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG BMS-986253
- DRUG Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine
- DRUG Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2023-07-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05148234
The ClinicalTrials.gov registry entry for NCT05148234 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.
NCT05148234 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05148234 about?
NCT05148234 is a clinical study titled "BMS-986253 in Myelodysplastic Syndromes". Background: The myelodysplastic syndromes (MDS) are a group of bone marrow neoplasms. MDS mostly affect elderly people. The drugs used to treat MDS are not always effective, and the only curative treatment is stem cell transplant. Researchers want to see if a new drug can be used to treat MDS. Obj...
What is the current status of trial NCT05148234?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-11-29. Estimated completion is 2023-07-03.
What interventions are being tested in trial NCT05148234?
The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), BMS-986253 (DRUG), Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine (DRUG), Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT05148234?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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