NCT04146038

Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease

Salsalate + Venetoclax/Decitabine for Patients With Acute Myelogenous Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of salsalate when added to venetoclax and decitabine or azacitidine in treating patients with acute myeloid leukemia or myelodysplasia/myeloproliferative disease that has spread to other places in the body (advanced). Drugs used in chemotherapy, such as salsalate, venetoclax, decitabine, 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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the tolerability of the addition of standard dose salsalate to the standard treatment combination of venetoclax + hypomethylating agent (HMA) (decitabine or azacitidine \[5-azacytidine\]). SECONDARY OBJECTIVES: I. Determine the remission rate and, when feasible, perform exploratory studies of: Ia. Patterns of mutation clearance. Ib. Distribution of cells with low and high reactive oxygen species (ROS) content at various points during therapy. OUTLINE: CYCLE 1: Patients receive salsalate orally (PO) twice daily (BID) until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine intravenously (IV) for 10 days or azacitidine IV for 7 days. Starting 24 hour after salsalate, patients also receive venetoclax PO continuously until completion of cycle 1. CYCLE 2: Patients receive decitabine IV for 5 days or azacitidine IV for 7 days, salsalate PO BID, and venetoclax PO continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Myeloblasts 10 Percent or More of Bone Marrow Nucleated Cells
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given IV
DRUG	Decitabine	Given IV
DRUG	Salsalate	Given PO
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-10-25
• Completion: 2022-10-25
• First posted: 2019-10-31
• Last updated: 2023-05-24
• Results posted: 2023-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study