Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483906
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Venetoclax and Azacitidine Combined With Homoharringtonine Followed by Allo-HSCT for Intermediate and High-risk AML
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:
Efficacy and Safety of Venetoclax and Azacitidine Combined With Low-Intensity Homoharringtonine Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplantation in IntermediateHigh-Risk Newly Diagnosed Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a single-center single-arm prospective phase II clinical trial evaluating the efficacy and safety of the VAH Venetoclax and Azacitidine combined with Homoharringtonine regimen followed by allo-HSCT for intermediate and high-risk AML Eligible patients receive two cycles of the VAH chemotherapy regimen If minimal residual disease MRD is negative after these two cycles patients proceed to the transplantation process If MRD remains positive patients receive an additional two cycles of the VAH regimen Upon achieving MRD negativity they then proceed to the transplantation process
The conditioning regimen includes fludarabine at 30 mgm²day from day -7 to day -3 5 days cytarabine at 1-15 gm²day from day -7 to day -3 5 days and busulfan at 32 mgkgday from day -5 to day -3 3 days Conditioning begins on day -6 and donor hematopoietic stem cell infusion is performed on day 0
All patients will undergo bone marrow examination on day 14 and day 28 post-transplant followed by bone marrow examinations every 30 days within the first year after transplantation and every 60 days within the second year If disease relapse is suspected during the follow-up period bone marrow or extramedullary relapse site examinations will be conducted at any time
The primary endpoint is the 1-year and 2-year overall survival OS Secondary endpoints include the complete response CR rate after 1 and 2 cycles of chemotherapy 1-year and 2-year disease-free survival DFS following the achievement of CR through induction therapy cumulative relapse rate non-relapse mortality NRM incidence of acute graft-versus-host disease GVHD within 180 days post-transplant and the cumulative incidence of chronic GVHD within 1 year and 2 years post-transplant
The conditioning regimen includes fludarabine at 30 mgm²day from day -7 to day -3 5 days cytarabine at 1-15 gm²day from day -7 to day -3 5 days and busulfan at 32 mgkgday from day -5 to day -3 3 days Conditioning begins on day -6 and donor hematopoietic stem cell infusion is performed on day 0
All patients will undergo bone marrow examination on day 14 and day 28 post-transplant followed by bone marrow examinations every 30 days within the first year after transplantation and every 60 days within the second year If disease relapse is suspected during the follow-up period bone marrow or extramedullary relapse site examinations will be conducted at any time
The primary endpoint is the 1-year and 2-year overall survival OS Secondary endpoints include the complete response CR rate after 1 and 2 cycles of chemotherapy 1-year and 2-year disease-free survival DFS following the achievement of CR through induction therapy cumulative relapse rate non-relapse mortality NRM incidence of acute graft-versus-host disease GVHD within 180 days post-transplant and the cumulative incidence of chronic GVHD within 1 year and 2 years post-transplant
Detailed Description:
None
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