Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06220487
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-12-03
Brief Title:
A Single-arm Open-label Study of Olverembatinib CD3CD19 Bispecific T-cell Engager and Chidamide in Patients With Newly Diagnosed PhALL
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
A Single-arm Open-label Study of Olverembatinib CD3CD19 Bispecific T-cell Engager and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ABC
Brief Summary:
ABC study is a phase 2 single-arm open-label study of Olverembatinib CD3CD19 Bispecific T-cell Engager and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia PhALL This study combined third generation TKI Olverembatinib histone deacetylase inhibitors Chidamide and CD3CD19 bispecific T-cell engager Blinatumomab as first line regimen ABC regimen for Ph ALL Investigatorsaim to explore the efficacy and safety of ABC regimen The primary endpoint is the complete molecular remission CMR at 3 months secondary endpoints are overall survival OS event-free survival EFS adverse event AE IKZF1del IKZF1plus IKZF1lpusCD20 subgroup EFSOS
Detailed Description:
Philadelphia chromosome-positive acute lymphoblastic leukemia PhALL is now a relatively favorable-risk leukemia with the development of potent BCRABL1 tyrosine kinase inhibitors TKIs Achievement of an early and deep complete molecular remission CMR is an important end point in Ph ALL and identifies patients who may not need allogeneic hematopoietic stem cell transplantation allo-HSCT The chemotherapy-free D-ALBA trial of dasatinib and blinatumomab was safe and effective in patients with newly diagnosed Ph-positive ALL and resulted in an estimated 3-year OS rate of 80 NEJM 2020 2022 To further improve the outcomes the potent third-generation TKIs ponatinib and olverembatinib ASH 2023 abs 1504 were added to chemotherapy or immunotherapy resulted in an overall CMR rate of 84-90 a 5-year survival rate of 73 most patients did not undergo allo-HSCT
Of note IKZF1plus subgroup still stands for high-risk for PhALL and exhibit poor outcome even in TKI plus blinatumomab which indicate IKZF1del confers resistance to immunotherapy our previous study found that HDACi tucidinostatchidamide could restore the expression and functionality of IKZF1 in IKZF1del samples including increased expression of CD19 and reduced focal adhesion Blood 2021 138 Supplement 1 514
ABC study is a phase 2 single-arm open-label study of Olverembatinib CD3CD19 Bispecific T-cell Engager and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia PhALL This study combined third generation TKI Olverembatinib histone deacetylase inhibitors Chidamide and CD3CD19 bispecific T-cell engager Blinatumomab as first line regimen ABC regimen for Ph ALL Investigators aim to explore the efficacy and safety of ABC regimen The primary endpoint is the complete molecular remission CMR at 3 months secondary endpoints are overall survival OS event-free survival EFS adverse event AE IKZF1del IKZF1plus IKZF1lpusCD20 subgroup EFSOS
Of note IKZF1plus subgroup still stands for high-risk for PhALL and exhibit poor outcome even in TKI plus blinatumomab which indicate IKZF1del confers resistance to immunotherapy our previous study found that HDACi tucidinostatchidamide could restore the expression and functionality of IKZF1 in IKZF1del samples including increased expression of CD19 and reduced focal adhesion Blood 2021 138 Supplement 1 514
ABC study is a phase 2 single-arm open-label study of Olverembatinib CD3CD19 Bispecific T-cell Engager and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia PhALL This study combined third generation TKI Olverembatinib histone deacetylase inhibitors Chidamide and CD3CD19 bispecific T-cell engager Blinatumomab as first line regimen ABC regimen for Ph ALL Investigators aim to explore the efficacy and safety of ABC regimen The primary endpoint is the complete molecular remission CMR at 3 months secondary endpoints are overall survival OS event-free survival EFS adverse event AE IKZF1del IKZF1plus IKZF1lpusCD20 subgroup EFSOS
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?:
True
Is an FDA AA801 Violation?:
None