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NCT05184842 · ClinicalTrials.gov registry record · Phase 2
Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 3
- Study locations
NCT05184842 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 91 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (22% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05184842, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 3
- Study locations
Study Summary
Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability of the bone marrow to make these cells is decreased. The decreased bone marrow function is the result from abnormalities that develop in the malignant cells which prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. The malignant cells in the bone marrow are not good at maturing to make the components of the blood that you need, they occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. DNA is a chemical substance within cells that stores information needed for cell growth and cell behavior. One approach to treating the malignant cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Decitabine is FDA approved for treatment of MDS and AML. Venetoclax is approved for AML in combination with Azacitidine for patients with AML or are over age 75 or unfit for chemotherapy. In this study, Decitabine and venetoclax will be administered using a low dose weekly schedule in an attempt to improve efficacy by decreasing the side effects often seen when these drugs are given at standard dosing.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine
Study Locations (3)
New York
- Montefiore Medical Center - The Bronx
- White Plains Hospital - White Plains
California
- University of California Davis Health (UC Davis Health) - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2022-03-23 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05184842
The ClinicalTrials.gov registry entry for NCT05184842 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (22% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT05184842 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, California.
Frequently Asked Questions
What is clinical trial NCT05184842 about?
NCT05184842 is a clinical study titled "Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML". Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made. In ...
What is the current status of trial NCT05184842?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2022-03-23. Estimated completion is 2027-03.
What conditions does trial NCT05184842 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT05184842?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT05184842?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05184842 being conducted?
This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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