Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-27
Brief Title:
Decitabine Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
A Multicenter Prospective Phase II Study of Decitabine Venetoclax and Blinatumomab for Maintenance Following Allogeneic Hematopoietic Cell Transplantation in Patients With Ph-Negative B-Cell Acute Lymphoblastic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 study aims to evaluate whether maintenance therapy with decitabine venetoclax and blinatumomab could improve the 2-year progression free survival PFS of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission
Detailed Description:
This is a phase Ⅱ open-label single-arm multi-center study in patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in minimal residual disease-negative remission In this study patients will be treated with 4 cycles of maintence therapies for up to one year or until intolerable toxicity death withdrawal or study termination In cycle one and three patients will receive decitabine monotherapy and in cycle two and four patients will receive a combination of venetoclax and blinatumomab This study aims to evaluate whether maintenance therapy with decitabine venetoclax and blinatumomab could improve the 2-year progression free survival PFS of those patients and explore the efficiency and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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