NCT06232655

Cladribine Venetoclax in Monocytic AML

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cladribine	A medication used to treat hairy cell leukemia (leukemic reticuloendotheliosis) and B-cell chronic lymphocytic leukemia. Cladribine, sold under the brand name Mavenclad, is used for the treatment of adults with highly active forms of relapsing-remitting multiple sclerosis.
DRUG	Venetoclax	A medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).
DRUG	Azacitidine	Medication used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. It is a chemical analog of cytidine, a nucleoside in DNA and RNA.. Azacitidine and its deoxy derivative, decitabine were first synthesized in Czechoslovakia as potential chemotherapeutic agents for cancer.

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-01-31
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study