NCT05814731

Study on the Efficacy and Safety of MA-BUCY2 Conditioning in High-risk AML Patients Underwent Haplo-HSCT

A Randomized Controlled Study on the Efficacy and Safety of MA-BUCY2 Protocol in the Conditioning of Haploidentical Stem Cell Transplantation in Patients With High-risk Acute Myeloid Leukemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

According to the 2022 ELN guidelines patients with high-risk acute myeloid leukemia were randomly divided into MA-BUCY2 conditioning group and BuCy2 conditioning group，to evaluate the efficacy and safety of two conditioning regimens in haploidentical hematopoietic stem cell transplantation.

Detailed description

High risk acute myeloid leukemia patients were randomly divided into two groups before conditioning of haploidentical hematopoietic stem cell transplantation.The control group will use the BUCY2 conditioning，and the experimental group will use mitoxantrone liposome combined with BUCY2 for conditioning. After transplantation，we will observe the difference of one year relapse rates between two goups，also the adverse reactions of conditioning，GVHD，OS and PFS of the patients in two groups also been observed.

Conditions

• Haploidentical Stem Cell Transplantation
• Conditioning

Interventions

Type	Name	Description
DRUG	MA-BUCY2	Mitoxantrone liposome 20mg/m2，ivgtt，d-11 ；Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2
DRUG	BUCY2	Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2

Timeline

• Start date: 2023-04-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: China