Trial Outcomes & Findings for Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease (NCT NCT04146038)

NCT ID: NCT04146038

Last Updated: 2023-05-24

Results Overview

Study drug associated adverse events during therapy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: During the first 2 cycles, 56 days total
• Results posted on: 2023-05-24

Participant Flow

Participant milestones

Measure	Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) 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 STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) n=5 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: During the first 2 cycles, 56 days total

Study drug associated adverse events during therapy

Outcome measures

Measure

Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) n=5 Participants 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

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

1 Participants

SECONDARY outcome

Timeframe: During the first 2 cycles 56 days total

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

Outcome measures

Measure

Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) n=5 Participants 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

Number of Participants With Complete or Partial Response

1 Participants

Adverse Events

Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) n=5 participants at risk 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
Infections and infestations Febrile neutropenia	40.0% 2/5 • Number of events 4 • During the first two cycles (56 days), up to 2 years
Respiratory, thoracic and mediastinal disorders Lung infection	20.0% 1/5 • Number of events 2 • During the first two cycles (56 days), up to 2 years

Other adverse events

Measure	Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax) n=5 participants at risk 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
Blood and lymphatic system disorders Blood and lymphatic system disorders	100.0% 5/5 • Number of events 15 • During the first two cycles (56 days), up to 2 years
Investigations Investigations	100.0% 5/5 • Number of events 30 • During the first two cycles (56 days), up to 2 years
Gastrointestinal disorders Gastrointestinal disorders	40.0% 2/5 • Number of events 5 • During the first two cycles (56 days), up to 2 years
Metabolism and nutrition disorders Metabolism and nutrition disorders	40.0% 2/5 • Number of events 5 • During the first two cycles (56 days), up to 2 years
Vascular disorders Vascular disorders	40.0% 2/5 • Number of events 2 • During the first two cycles (56 days), up to 2 years
Cardiac disorders Cardiac disorders	20.0% 1/5 • Number of events 1 • During the first two cycles (56 days), up to 2 years
General disorders General disorders and administration site conditions	20.0% 1/5 • Number of events 4 • During the first two cycles (56 days), up to 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	20.0% 1/5 • Number of events 1 • During the first two cycles (56 days), up to 2 years
Nervous system disorders Nervous system disorders	20.0% 1/5 • Number of events 1 • During the first two cycles (56 days), up to 2 years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	20.0% 1/5 • Number of events 1 • During the first two cycles (56 days), up to 2 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	20.0% 1/5 • Number of events 1 • During the first two cycles (56 days), up to 2 years

Additional Information

Roger K. Strair, MD, PhD

Cancer Institute of New Jersey Rutgers

Phone: 732-235-4523

Email: strairrk@cinj.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place