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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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