Study on Low Dose Weekly Decitabine and Venetoclax for Treating MDS and AML
Sponsor: Montefiore Medical Center
ClinicalTrials ID:NCT05184842
This clinical trial is testing a new treatment approach using low doses of Decitabine and Venetoclax to help manage myeloid cancers like acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with fewer side effects.
Patient Parameters
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Program Overview
Myeloid cancers, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), affect the bone marrow, which is responsible for producing blood cells. These cancers can lead to bone marrow failure, reducing the production of red blood cells, white blood cells, and platelets. Traditional treatments often involve chemotherapy that damages DNA in cancer cells, but this can also harm normal cells and cause side effects. This study explores a new approach using low doses of Decitabine and Venetoclax, aiming to reduce side effects while effectively treating the cancer.
Description
This study is testing a new treatment method for patients with myeloid cancers like AML and MDS. The standard treatment with Azacitidine and Venetoclax can cause significant side effects, especially in patients with poor bone marrow function or other health issues. This trial will use lower doses of Decitabine and Venetoclax to see if it can be effective with fewer side effects.
The study will have two phases. In the first phase, 33 patients will be enrolled to test the safety and tolerability of the treatment. In the second phase, up to 91 patients will be included to further evaluate the treatment's safety and effectiveness. Patients will receive treatment for at least 12 weeks, and those who respond well may continue treatment longer.
Decitabine will be given once or twice a week, and Venetoclax will be taken once a week. The goal is to find a balance where the treatment is effective but causes fewer side effects. This study is open to patients who cannot tolerate standard treatments or who have not benefited from them.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or related conditions confirmed by a specialist.
- Must be 18 years or older.
- Must have a performance status score of 3 or higher, indicating some level of disability but still able to perform self-care.
- Must have adequate liver and kidney function as determined by specific blood tests.
- Must be able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Cannot have acute promyelocytic leukemia (APL) or certain types of AML that are better treated with chemotherapy.
- Cannot have had previous treatment with Azacitidine, Decitabine, or Venetoclax.
- Cannot be currently pregnant or breastfeeding.
- Cannot have uncontrolled illnesses that could affect life expectancy or study participation, such as active infections or severe heart conditions.
- Cannot have a history of severe allergic reactions to Decitabine or Venetoclax.
- Must agree to use effective birth control methods during the study if of childbearing potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Davis Health (UC Davis Health) | 95817 | Sacramento | California |
| Montefiore Medical Center | 10467 | The Bronx | New York |
| White Plains Hospital | 10601 | White Plains | New York |
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