Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.

NCT Number	NCT06504459
Lead Sponsor	OHSU Knight Cancer Institute Collaborators: Oregon Health and Science University, AbbVie
Conditions	Acute Monocytic Leukemia, Acute Myeloid Leukemia
Enrollment	40 participants
Start Date	2025-01-03
Primary Completion	2027-10-11 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-13