Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of study treatment with the exception of hydroxyurea, which is allowed throughout the study for the control of peripheral leukemia blasts in patients with white blood cell counts >30,000/μL
Major surgery within 4 weeks prior to planned start of study treatment
Active, uncontrolled clinically significant systemic bacterial, viral, fungal, or parasitic infection, or an unexplained fever >101.3°F during screening or on the first day of study treatment
Another concurrent malignancy requiring active therapy
Active central nervous system involvement
Any unresolved toxicities from prior therapy > grade 2 as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 at the time of starting study treatment, except for alopecia
History of hematopoietic stem cell transplant, or CAR-T therapy within 60 days of the first dose of study treatment, or with any of the following:
- Ongoing immunosuppressive therapy post-HSCT or CAR-T therapy at the time of screening with the exception of use of low-dose corticosteroids ≤10 mg prednisone or equivalent and topical steroids for ongoing skin graft-versus-host disease (GVHD), or clinically significant GVHD, or need for anticytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > grade 1 from CAR-T therapy
Clinically significant cardiovascular disease with history of myocardial infarction within 6 months prior to planned start of study treatment; New York Heart Association (NYHA) class III or IV congestive heart failure; unstable angina; LVEF <40% by echocardiogram (ECG) or multigated acquisition scan within 28 days of C1D1; known history of severe and/or uncontrolled ventricular arrhythmia within 6 months prior to planned start of study drug; prolongation of the QT interval corrected for heart rate (QTcF) >470 msec on at least two out of three consecutive ECGs, and mean QTcF >470 msec on all three ECGs, during screening
Active HIV and/or hepatitis B or C virus (patients with controlled hepatitis B or successfully treated hepatitis C >4 weeks between achieving sustained viral response and starting study drug are eligible)
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong p-gp inhibitor with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4 who are being evaluated for arm B
Treatment with proton pump inhibitor within 7 days of starting study drug
Any serious underlying medical or psychiatric condition, dementia, or altered mental status, or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient’s participation in the study or confound the results of the study
Pregnancy, lactation, or plan to breastfeed during the study or within 30 days of the last dose of study treatment
Known hypersensitivity to any components of the study drug or its formulation

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