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

April 14, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xiaonig wang, M.D.
  • Phone Number: 0086-18991232608
  • Email: wangxn99@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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:

    1. Long QTc syndrome or QTc interval>480 ms;
    2. Complete left bundle branch block, II or III degree atrioventricular block;
    3. Serious and uncontrolled arrhythmia requiring drug treatment;
    4. American New York Heart Association rating ≥ III;
    5. Cardiac ejection fraction (LVEF) is less than 60%;
    6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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
Other Names:
  • cyclophosphamide
  • cytarabine
  • busulfan
  • anti-thymocyte immunoglobulin
  • Mitoxantrone liposome
  • semustine
Active Comparator: 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；
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
Other Names:
  • Cytarabine
  • cyclophosphamide
  • busulfan
  • anti-thymocyte immunoglobulin
  • semustine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse rates
Time Frame: one year after transplantation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: from beginning of the conditioning to one month after conditioning
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
aGVHD
Time Frame: At day 100 post-transplantation
the incidence of acute graft versus host disease
At day 100 post-transplantation
OS
Time Frame: 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.
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.
PFS
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Xiaoning Wang, M.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022SJ-XK005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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