Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Acute Myeloid Leukemia Clinical Trial

Official title: Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure: A University of California Hematologic Malignancies Consortium Protocol

Status Recruiting

Clinical Trial Summary

This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, 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.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of venetoclax plus alternative hypomethylating agent (HMA), as defined by the primary endpoint of overall response rate, for patients with treatment naive acute myeloid leukemia (AML) eligible for venetoclax plus HMA with prior HMA failure.

SECONDARY OBJECTIVES:

I. To further examine the efficacy of venetoclax plus alternative HMA for patients with treatment naive AML eligible for venetoclax plus HMA with prior HMA failure using additional efficacy endpoints.

II. To further evaluate the safety of venetoclax plus alternative HMA for patients with treatment naive AML eligible for venetoclax plus HMA with prior HMA failure. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrent Acute Myeloid Leukemia

• NCT number: NCT04905810
• Study type: Interventional
• Source: University of California, Davis
• Status: Recruiting
• Phase: Phase 2
• Start date: February 9, 2022
• Completion date: December 1, 2025