Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401603
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-02
Brief Title:
A Phase I Study of Decitabine Lisaftoclax and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CRCR 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 MR45 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
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 CRCR 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 MR45 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03867 | OTHER | NCI-CTRP Clinical Registry | None |