Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507514
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Blinatumomab and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Allogeneic hematopoietic stem cell transplantation allo-HSCT is the main method potentially curing adult B-ALL but the high treatment-related mortality NRM affects overall survival OS Autologous stem cell transplantation auto-HSCT can significantly reduce NRM but has a higher relapse rate Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse achieving similar efficacy to allo-HSCT The efficacy of blinatumomab in clearing MRD has been confirmed Therefore using blinatumomab combined with Auto-HSCT for B-ALL patients seems to make it possible to achieve benefits in leukemia free survivalLFS and OS The investigators first conducted blinatumomab and auto-HSCT sandwich strategy as consolidation therapy in patients with B-ALL The main Purpose of this study was to observe the safety and efficacy of this new strategy
Detailed Description:
Enrolled patients received induction chemotherapy with the IVP regimen and two cycles of consolidation chemotherapy high-dose cytarabine Ara-c pegaspargase Tyrosine kinase inhibitors TKI and methotrexate MTX pegaspargase TKI Sequential treatment with blinatumomab was then administered After the first treatment with blinatumomab autologous stem cell mobilization and collection were performed Following successful stem cell collection autologous stem cell transplantation was conducted Starting from the third month after autologous stem cell transplantation the second maintenance treatment with blinatumomab was administered with one cycle every three months for a total of four cycles Long-term follow-up monitoring was then conducted The follow-up period for this study was two years and data on two-year LFS OS and NRM rates were collected
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?:
None