Decitabine, Lisaftoclax, and Olverembatinib in Advanced CML and Philadelphia Chromosome-Positive AML [USA]
Study title
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Scientific title
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Type of study
Treatment of advanced phases
Phase
Current status
Recruiting
Other trial ID
NCI-2024-03867; 2024-0032; ClinicalTrials.gov NCT06401603
What is the purpose of the study
This is a study to find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-positive Acute Myeloid Leukemia (Ph+ AML).
What will happen during the study
Participants in this phase I study will receive decitabine as injection into a vein (intravenous), and lisaftoclax and olverembatinib by mouth (orally). The dose of lisaftoclax will depend on when participants join the study. Up to 2 dose levels of lisaftoclax will be tested. Between 3-12 participants will be enrolled at each dose level.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have been diagnosed with CML in advanced phase (AP), CML in myeloid bastic phase (MBP), or Ph+ AML, as defined by the WHO 2016 criteria
- who are resistant or intolerant to at least one previous BCR::ABL1 tyrosine kinase inhibitor (TKI) for treatment of their CML
- have an Eastern Co-Operative Group (ECOG) status of 0, 1, 2 or 3
- have adequate liver, heart, kidney and pancreas function, as defined in the study protocol.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have been treated with lisaftoclax and olverembatinib
- have had acute pancreatitis within 1 year of study entry, or have a history of chronic pancreatitis
- have active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- have clinically significant and uncontrolled cardiovascular disease.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.
Study sponsor
M.D. Anderson Cancer Center in collaboration with Ascentage Pharma Group Inc.
Scientific lead / contact
Nicholas Short, MD, M.D. Anderson Cancer Center
Principal investigator
Nicholas Short, MD, M.D. Anderson Cancer Center
Study centers / principal investigators
United States
Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigtor: Nicholas Short