NCT06758726

Mitoxantrone Hydrochloride Liposome Combined With BU/Cy Were Used as a Conditioning Regimen for Patients With Intermediate/Adverse Risk or Persistently Positive MRD AML

Mitoxantrone Hydrochloride Liposome Injection Combined With Bu/Cy Conditioning on Acute Myeloid Leukaemia Patients With Intermediate/Adverse Risk Disease or Persistently Positive MRD Undergoing Allogeneic Haematopoietic Stem-cell Transplantation: a Prospective, Single-center, Exploratory Clinical Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT)

Detailed description

The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT Mitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML. Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7\~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3\~-2, iv

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome combined with BU/Cy	Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7\~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3\~-2, iv

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-01-06
• Last updated: 2025-01-06