A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objectives • To establish the minimum safe and biologically-effective dose of lisaftoclax and olverembatinib in combination with decitabine Secondary Objectives * To determine the rate of conversion to CML-CP for participants with advanced phase CML or complete remission (CR)/CR with incomplete hematology recovery (CRi) for participants with Ph+ AML, within 4 cycles of combination therapy * To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry, rates of CCyR, MMR, MR4 and MR4.5, relapse-free survival, overall survival) * To assess prop…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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: 1. 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 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x ULN, unless due to the under…
Interventions
- DrugDecitabine
Given by IV
- DrugListaftoclax
Given by PO
- DrugOlverembatinib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas