Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554626
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Regimen of Blinatumomab and Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating Precursor B Cell Acute Lymphoblastic Leukemia A Phase II Single Arm and Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Precursor B cell acute lymphoblastic leukemia B-ALL is an aggressive type of leukemia with high relapse rate and poor long term survival in adults Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation In the past decade with the application of molecular targeted drugs and immunotherapy the survival of B-ALL patients has significantly improved In this studywe propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults Our study aims to answer the safety and efficacy of this treatment regimen and further improve the survival for those participants
Detailed Description:
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 2-year event free survivalEFS
The induction therapy is a combination of BlinatumomabBlina VenetoclaxVen and DexamethasoneDXM and would be applied for two cycles As for consolidation the Inotuzumab OzogamicinINO would be given on cycle 3 and cycle 5 The high dose of MTX would be given on Cycle 4 and the Ven plus L-asp would ben given on Cycle 6 Subsequent maintenance therapy contains of low dose of Chemotherapy Blina and INO
The purpose of this study is to explore the safety and efficacy of the whole-process management of multi-drug combination regimen in the treatment of newly diagnosed Ph-negative B-ALL patients
The induction therapy is a combination of BlinatumomabBlina VenetoclaxVen and DexamethasoneDXM and would be applied for two cycles As for consolidation the Inotuzumab OzogamicinINO would be given on cycle 3 and cycle 5 The high dose of MTX would be given on Cycle 4 and the Ven plus L-asp would ben given on Cycle 6 Subsequent maintenance therapy contains of low dose of Chemotherapy Blina and INO
The purpose of this study is to explore the safety and efficacy of the whole-process management of multi-drug combination regimen in the treatment of newly diagnosed Ph-negative B-ALL patients
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