Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841771
Status:
RECRUITING
Last Update Posted:
2023-05-08
First Post:
2023-04-24
Brief Title:
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies
Sponsor:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Single Arm Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With f High-risk Myeloid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation
Detailed Description:
This is a prospective single-arm study Patients with high-risk AML or MDS aged between 18-70 years old will enroll in the study They will be given hypomethylating agents azacytidine 32mgm2 or decitabine 5mgm2 for 5 days and venetoclax 400mgd for 7 days after allogeneic hematopoietic stem cell transplantation The maintenance therapy will start from 60th days posttransplant repeated every 28 days until up to 1-year posttransplant The 1-year leukemia-free survival rate1-year cumulative recurrence rate and 1-year overall survival will be analyzed
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