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About
This phase I/II trial studies the side effects and best dose of milademetan tosylate and to see how well it works with cytarabine with or without ventoclax in treating participants with acute myeloid leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Milademetan tosylate and ventoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, 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. It is not yet known if giving milademetan tosylate and low-dose cytarabine with or without ventoclax will work better in treating participants with recurrent or refractory acute myeloid leukemia.
Full description
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study.
If you are enrolled in Phase 1, the dose of DS-3032b you receive will depend on when you join this study.
If you are enrolled in Phase 2, you will receive DS-3032b at the highest dose that was tolerated in Phase 1.
All participants will receive LDAC at a fixed dose (meaning the dose will not change). If you are assigned to receive it, your dose of venetoclax will not change either. However, if needed because you have side effects, your dose may be adjusted.
Up to 58 participants will be enrolled in this study. All will take part at MD Anderson.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) 2016 criteria. Patients will be divided into 2 arms during the phase 2 portion:
TP53 wild-type status on molecular testing performed within the last 3 months
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Creatinine clearance >= 60 mL/min, as calculated using the modified Cockcroft-Gault equation OR creatinine =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN
Bilirubin =< 1.5 x ULN, unless resulting from hemolysis, Gilbert's disease or considered to be due to leukemic involvement
No gastrointestinal issues to interfere with oral medication absorption
No active uncontrolled infection or comorbidity that would interfere with therapy or place patient at increased risk
Subject (male and female) of childbearing/reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug
Subject must sign and date an Institutional Review Board-approved informed consent form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study-specific procedures or tests
Able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
Willing to undergo malignancy genotyping for TP53 mutation, insertion, or deletion at screening
Use of hydroxyurea is allowed prior to and during the first cycle of study treatment. 1-2 doses of cytarabine are also permitted if needed for cytoreduction prior to initiating study treatment
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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