Spots Global Cancer Trial Database for A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Study Description

Brief 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.

Detailed 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 proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation * To determine the safety of the combination regimen Exploratory Objectives * To evaluate the impact of olverembatinib monotherapy on signaling pathways and apoptotic protein expression * To assess relationship between baseline signaling pathway activation and apoptotic protein expression on response and long-term outcomes such as overall survival (OS) and relapse free survival (RFS).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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