Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385808
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of RR AML
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid 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:
The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia The secondary purpose of the study was to observe the safety of MTBF regimen in these patients
Detailed Description:
High-intensity conditioning regimen prior to allogeneic hematopoietic stem cell transplantation allo-HSCT can maximize the clearance of leukemia cells but is often associated with increased pretreatment-related toxicity and transplant-related mortality In order to enhance its anti-tumor effect without increasing or even decreasing its tissue toxicity and then prolong the overall survival of AML patients we optimized the conditioning regimen before allo-HSCT transplantation 1 The classical ThiotepaBusulfanFludarabine TBF regimen will be adopted to reduce the conditioning associated toxicity ensure graft implantation to the maximum extent and reduce the recurrence rate ② At the same time mitoxantrone hydrochloride liposome will be added to avoid the disadvantages of weak immunosuppressive effect and weak anti-leukemia effect and MTBF pretreatment scheme will be finally explored It has been applied in the pre-treatment of salvage allo-HSCT in 3 patients with relapsed and refractory acute myeloid leukemia with good safety Up to the present follow-up time of 4 months all 3 patients have disease free survival To evaluate the safety and efficacy of this protocol we intend to include more patients undergoing salvage allo-HSCT for relapsed or refractory RR AML
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