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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05814731
Other study ID # XJTU1AF2022SJ-XK005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source First Affiliated Hospital Xi'an Jiaotong University
Contact xiaonig wang, M.D.
Phone 0086-18991232608
Email wangxn99@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
China First Affiliated Hospital of Xian Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary relapse rates blast cells in bone marrow are greater than or equal to 5%. Blast cells can be seen in peripheral blood or extramedullary relapse occurred. one year after transplantation
Secondary AEs adverse reactions of conditioning regimen include nausea, vomiting, abdominal pain, diarrhea, heart, liver and kidney toxicity from beginning of the conditioning to one month after conditioning
Secondary aGVHD the incidence of acute graft versus host disease At day 100 post-transplantation
Secondary OS overall survival From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.
Secondary PFS progression free survival From date of HSCT until the end of follow-up or the date of disease relapse from any cause, whichever came first,assessed up to 36 months.
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