NCT06401603

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Chronic Myeloid Leukemia
• Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Decitabine	Given by IV
DRUG	Listaftoclax	Given by PO
DRUG	Olverembatinib	Given by PO

Timeline

• Start date: 2024-08-06
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2024-05-06
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study