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

NCT05814731 | Unknown

• 1 other identifier: XJTU1AF2022SJ-XK005
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haploidentical Stem Cell Transplantation; Conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AEs

  from beginning of the conditioning to one month after conditioning

• aGVHD

  At day 100 post-transplantation

• OS

  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.

• PFS

  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.

Study Arms (2)

MA-BUCY2

EXPERIMENTAL

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: MA-BUCY2

BUCY2

ACTIVE COMPARATOR

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

Interventions

MA-BUCY2 DRUG

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

Also known as: Mitoxantrone liposome, cytarabine, busulfan, cyclophosphamide, semustine, anti-thymocyte immunoglobulin

MA-BUCY2

BUCY2 DRUG

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

Also known as: Cytarabine, busulfan, cyclophosphamide, semustine, anti-thymocyte immunoglobulin

BUCY2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the diagnostic criteria of 2022 ELN guidelines for high-risk acute myeloid leukemia;
• Patients with allogeneic stem cell transplantation indications;
• Age 18-60 (including upper and lower limits) ;
• No gender limit;
• ECOG score 0\~2 points;
• Flow MRD was negative before transplantation;
• The organ function level must meet the following requirements: a) Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal value (ULN), Total bilirubin (TBIL) ≤ 1.5 × ULN； b) Kidney: blood creatinine ≤ 1.5 × ULN； c) Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN； d) Normal cardiac function: that is, the ECG is normal or abnormal without clinical significance, and the left ventricular ejection fraction (LVEF) is greater than 60 or myocardial zymogram CK-MB is normal, pro-BNP is less than 900 pg/ml;
• The results of serum pregnancy test of female subjects with reproductive ability must be negative before the first use of the test drug;

You may not qualify if:

• Previously received doxorubicin or other anthracycline drugs, and the total cumulative dose of doxorubicin was more than 360 mg/m2;
• Hypersensitivity to any study drug or its components;
• Cardiac function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval\>480 ms;
• Complete left bundle branch block, II or III degree atrioventricular block;
• Serious and uncontrolled arrhythmia requiring drug treatment;
• American New York Heart Association rating ≥ III;
• Cardiac ejection fraction (LVEF) is less than 60%;
• History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system.;\\
• Active infection of hepatitis B and hepatitis C;
• Human immunodeficiency virus (HIV) infection;
• Patients with other malignant tumors;
• Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• Have a history of abuse of drugs;
• History of mental illness or cognitive impairment; .Other researchers judged that it was not suitable for this study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Interventions

Cytarabine; Busulfan; Cyclophosphamide; Semustine

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Lomustine; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds

Study Officials

• Xiaoning Wang, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaonig wang, M.D.

CONTACT

0086-18991232608; wangxn99@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 18, 2023
• Study Start: April 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)