Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308588
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-07
Brief Title:
Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic 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 learn if the combination of blinatumomab and asciminib can help to control Ph ALL
Detailed Description:
Primary Objectives
Phase I To determine the minimum safe and biologically effective dose of asciminib in combination with asciminib
Phase II To evaluate the rate of NGS measurable residual disease MRD negativity using the clonoSEQ assay in cohort 1 newly diagnosed Ph-positive ALL and the overall response CRCRi rate in cohort 2 relapsedrefractory disease
Secondary Objectives
To evaluate other clinical efficacy endpoints complete molecular response CMR rate CR rate relapse-free survival and overall survival
To determine the safety of the combination regimen
Exploratory Objectives
To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse
To assess concordancediscordance between MRD assessed by PCR for BCRABL1 and next-generation sequencing MRD
To determine the effect of the combination regimen on immune cell subsets
Phase I To determine the minimum safe and biologically effective dose of asciminib in combination with asciminib
Phase II To evaluate the rate of NGS measurable residual disease MRD negativity using the clonoSEQ assay in cohort 1 newly diagnosed Ph-positive ALL and the overall response CRCRi rate in cohort 2 relapsedrefractory disease
Secondary Objectives
To evaluate other clinical efficacy endpoints complete molecular response CMR rate CR rate relapse-free survival and overall survival
To determine the safety of the combination regimen
Exploratory Objectives
To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse
To assess concordancediscordance between MRD assessed by PCR for BCRABL1 and next-generation sequencing MRD
To determine the effect of the combination regimen on immune cell subsets
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-2024-02121 | OTHER | NCI-CTRP Clinical Registry | None |