Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTerrence J Bradley, MD
About this trial
This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.
Eligibility criteria
Qualifiers
Total bilirubin ≤ 2 upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin is ≤ 1.5 x ULN of the direct bilirubin.
Alanine aminotransferase (ALT) and aspartate transaminase (AST) must be ≤ 3 × ULN.
Calculated creatinine clearance > 50 ml/min.
Hemoglobin > 8 g/dL (prior red blood cell (RBC) transfusion allowed). Patients may be transfused to achieve this value. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed.
Disqualifiers
Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)
Cardiomyopathy or history of ischemic heart disease. Exception: Patients with ischemic heart disease who have received treatment for acute coronary syndrome (ACS), myocardial infarction (MI), and/or coronary artery revascularization surgery (e.g., coronary artery bypass graft, stent) greater than 6 months before screening and who are without cardiac symptoms may enroll.
Congestive heart failure (New York Heart Association (NYHA) Class III or IV or Class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening).
Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing).
Trial design
Treatments tested in this trial
- Bomedemstat
- Venetoclax
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Terrence J Bradley, MD
Lead sponsor
University of Miami
Sponsor institution
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Collaborator
Source ClinicalTrials.gov