Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390306
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-18
Brief Title:
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors TKIs combined with azacitidine and B-cell lymphoma-2 Bcl-2 inhibitor in patients with myeloid blast phase chronic myeloid leukemia CML-MBP
Detailed Description:
CML-MBP has dismal outcome Currently there is no standardized induction treatment approach in CML-MBP The European LeukemiaNet ELN recommendations and NCCN guideline recommended the combination of TKI and chemotherapy in CML-MBP The previous study revealed that TKI combined with hypomethylating agents had promising efficacy However imatinib and second generation TKI are the most widely applied in combination treatment there is limited data in third generation TKI
Currently venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with AML unsuitable for intensive induction chemotherapy Maiti et al reported that TKI combined with venetoclax and detectable had promising efficacy in CML-MBP Therefore the investigator conducted a study to explore the efficacy and safety of a third generation TKI in combination with azacitidine and Bcl-2 inhibitor in CML-MBP and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome
Currently venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with AML unsuitable for intensive induction chemotherapy Maiti et al reported that TKI combined with venetoclax and detectable had promising efficacy in CML-MBP Therefore the investigator conducted a study to explore the efficacy and safety of a third generation TKI in combination with azacitidine and Bcl-2 inhibitor in CML-MBP and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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