RecruitingPhase 2NCT05184842

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML


Sponsor

Montefiore Medical Center

Enrollment

91 participants

Start Date

Mar 23, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a low-dose combination of two blood cancer drugs — decitabine and venetoclax — in people with certain blood cell disorders. Researchers want to see if using these drugs at lower doses, given weekly, is safer and still effective. **You may be eligible if...** - You have been diagnosed with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or a related blood disorder - You are 18 years or older - Your liver and kidney function are within acceptable ranges - You have not previously been treated with azacitidine, decitabine, or venetoclax **You may NOT be eligible if...** - You have a specific type of leukemia called acute promyelocytic leukemia (APL) - You have previously received any of the study drugs - You are pregnant or breastfeeding - You have uncontrolled infections, severe heart failure, or unstable heart conditions - You have uncontrolled HIV infection - You are allergic to either study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle)

DRUGDecitabine

Decitabine 0.2 mg/kg subcutaneous (SQ) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)


Locations(3)

University of California Davis Health (UC Davis Health)

Sacramento, California, United States

Montefiore Medical Center

The Bronx, New York, United States

White Plains Hospital

White Plains, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05184842


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