Ignite Creation Date:
2025-12-18 @ 8:23 AM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT06742515
Status:
None
Last Update Posted:
2024-12-19 00:00:00
First Post:
2024-12-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL
Sponsor:
None
Organization:
Study Overview
Official Title:
Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study
Status:
None
Status Verified Date:
2024-09
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, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bone marrow transplantation. The purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young Ph-negative B-ALL patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: