Decitabine + Lisaftoclax + Olverembatinib for Leukemia
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken strong inducers of CYP3A or p-glycoprotein within 14 days before starting the study, and certain recent treatments are restricted. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination Decitabine + Lisaftoclax + Olverembatinib for Leukemia?
Research shows that Decitabine, when combined with other drugs like venetoclax, has been effective in treating acute myeloid leukemia (AML), especially in older patients or those unfit for intensive chemotherapy. This combination has led to high rates of complete remission and improved overall survival in these patients.12345
What makes the drug combination of Decitabine, Lisaftoclax, and Olverembatinib unique for leukemia treatment?
Research Team
Nicholas Short
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with advanced chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute myeloid leukemia (Ph+ AML). Participants should not have had previous treatments that failed. Specific health conditions and medications may exclude some individuals.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive varying doses of lisaftoclax in combination with decitabine and olverembatinib to establish the minimum safe and biologically-effective dose
Phase II Treatment
Participants receive lisaftoclax at the recommended dose found in Phase I, in combination with decitabine and olverembatinib
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and survival outcomes
Treatment Details
Interventions
- Decitabine
- Lisaftoclax
- Olverembatinib
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Ascentage Pharma Group Inc.
Industry Sponsor