Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT06401603
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).
Study:
NCT06401603
Study Brief:
Protocol Section:
NCT06401603