A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.
∙ a) Diagnosis: Age ≥18 years with CML-AP, CML-MBP, or Ph+ AML by WHO 2016 criteria.
• Participants must have been intolerant or resistant to at least one prior BCR::ABL1 TKI
• 2\. Performance status ≤3 (ECOG Scale).
• 3\. Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:
⁃ Total serum bilirubin \< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
⁃ Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x ULN, unless due to the underlying leukemia approved by the PI
⁃ Creatinine clearance ≥30 mL/min
⁃ Serum amylase or lipase \< 1.5 x ULN
‣ 4\. Ability to understand and the willingness to sign a written informed consent document
‣ 5\. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence,, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide.