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Venetoclax

Azacitidine

Decitabine

Salicylsalicylic acid

Sodium Salicylate

Salicylates

Antimetabolites

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

CYCLE 1: Patients receive salsalate PO BID until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine 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.

Salsalate

Roger K Strair

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.

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.

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

Study drug associated adverse events during therapy

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Professor of Medicine, Chief of Hematologic Malignancies Medical Oncology

CYCLE 1: Patients receive salsalate PO BID until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine 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.

Azacitidine: Given IV

Decitabine: Given IV

Salsalate: Given PO

Venetoclax: Given PO

Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Roger K. Strair, MD, PhD

Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine

Number of Participants With Complete or Partial Response

CYCLE 1: Patients receive salsalate by mouth daily ( PO BID) until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine 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.

Azacitidine: Given IV

Decitabine: Given IV

Salsalate: Given PO

Venetoclax: Given PO

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease	NCT04146038	Acute Myeloid L... Chronic Myelomo... Myeloblasts 10 ... Myelodysplastic... Myeloproliferat... Recurrent Acute... Refractory Acut... Secondary Acute...	Azacitidine Decitabine Salsalate Venetoclax	18 Years -	Rutgers, The State University of New Jersey
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease	NCT04146038	Acute Myeloid L... Chronic Myelomo... Myeloblasts 10 ... Myelodysplastic... Myeloproliferat... Recurrent Acute... Refractory Acut... Secondary Acute...	Azacitidine Decitabine Salsalate Venetoclax	18 Years -	Rutgers, The State University of New Jersey
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease	NCT04146038	Acute Myeloid L... Chronic Myelomo... Myeloblasts 10 ... Myelodysplastic... Myeloproliferat... Recurrent Acute... Refractory Acut... Secondary Acute...	Azacitidine Decitabine Salsalate Venetoclax	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for myeloblasts 10 percent or more of bone marrow nucleated cells