At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of MDS, AML, or MDS/MPN confirmed by hematopathology
- ✓Indication for HMA therapy with prior evidence of response to HMA
- ✓Age 18 years or older
- ✓Adequate AST and ALT levels
- ✕Acute promyelocytic leukemia (APL)
- ✕Core binding factor AML who are candidates for chemotherapy
- ✕Prior treatment with azacitidine, decitabine, or venetoclax
- ✕Other disease-directed therapy within 14 days (except hydroxyurea)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05184842Phase 2RecruitingUpdate OverdueUpdated 5mo ago · Completion was 30mo agoMetabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
In Brief
A Phase 2 clinical trial evaluating Venetoclax and Decitabine for Myelodysplastic Syndromes and 2 related conditions. Currently recruiting, targeting 91 participants across 3 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle)
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)