Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML

Hematopoietic Stem Cell Transplantation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Thiotepa/Busulfan/Fludarabine (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 (R/R) AML. ;

Related Conditions & MeSH terms

• Conditioning
• Hematopoietic Stem Cell Transplantation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Refractory Acute Myeloid Leukemia
• Relapse Leukemia

• NCT number: NCT06385808
• Study type: Interventional
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xiaoning Wang, M.D.
• Phone: 0086-18991232608
• Email: wangxn99@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: December 31, 2026