Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT07178912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.
Detailed Description:
Primary Objective
• To evaluate the rate of complete molecular response (CMR; undetectable BCR::ABL1 transcript by RT-PCR) in participants with newly diagnosed Ph-positive ALL and the overall response rate (complete remission + complete remission with incomplete count recovery) in participants with relapsed/refractory Ph-positive ALL
Secondary Objectives
* To evaluate event-free survival (EFS)
* To evaluate overall survival (OS)
* To evaluate MRD negativity by next-generation sequencing (NGS) at a sensitivity of 1x10-6
* To assess the safety of the regimen
• To evaluate the rate of complete molecular response (CMR; undetectable BCR::ABL1 transcript by RT-PCR) in participants with newly diagnosed Ph-positive ALL and the overall response rate (complete remission + complete remission with incomplete count recovery) in participants with relapsed/refractory Ph-positive ALL
Secondary Objectives
* To evaluate event-free survival (EFS)
* To evaluate overall survival (OS)
* To evaluate MRD negativity by next-generation sequencing (NGS) at a sensitivity of 1x10-6
* To assess the safety of the regimen
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06675 | OTHER | NCI-CTRP Clinical Registry | View |