Cladribine Venetoclax in Monocytic AML

Acute Myeloid Leukemia Clinical Trial

Official title: Study of Cladribine+Venetoclax After Failure of Venetoclax+Hypomethylating Agent in Monocytic AML

Status Not yet recruiting

Clinical Trial Summary

Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax

Clinical Trial Description

This is an investigator-initiated, open label, single institution, Study to assess the efficacy of Clad/Ven following failure of HMA/Ven in AML with a monocytic phenotype. In cycle 1, subjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 and venetoclax 400mg daily (following standard dose escalation over the first 3 days) on days 1 through 28 of a 28 day cycle. A bone marrow biopsy will be performed to assess response on day 28 of cycle 1. Subjects who respond to cycle 1, defined as achieving a CR, CRi, MLFS, or PR per ELN criteria, or a blast reduction of at least 50% from baseline, may continue on alternating 28-day consolidation cycles of Aza/Ven (even cycles) and Clad/Ven (odd cycles). Cycles will continue unless the subject needs to be removed from the study due to disease progression, treatment failure (defined as failure to achieve CR, CRi, or MLFS after 4 cycles of treatment), intolerance or toxicity, patient preference, or other reasons. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

• NCT number: NCT06232655
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Derek Schatz
• Phone: 720-848-0628
• Email: derek.schatz@cuanschutz.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2024
• Completion date: October 2027