Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML

December 20, 2024 updated by: Xiao-Ning Gao, Beijing 302 Hospital

Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed/refractory Acute Myeloid Leukemia

The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. This project initiates a prospective and exploratory clinical study on the DCMG chemotherapy regimen for the treatment of relapsed/refractory AML (Acute Myeloid Leukemia). The study aims to evaluate the efficacy and safety of the DCMG combination chemotherapy regimen in treating relapsed/refractory AML.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Estimated)

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.
20

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.
  • Phase 2

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: Dr. Gao Xiaoning, Chief Physician, Professor
  • Phone Number: 86+01066947169
  • Email: gaoxn@263.net

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient has fully understood the study, voluntarily agrees to participate, and has signed the Informed Consent Form (ICF);
  • Age between 18 and 75 years, with no gender restrictions;

  • Confirmed diagnosis of relapsed/refractory AML (Acute Myeloid Leukemia) by pathology (meeting any one of the following criteria):

    1. Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;
    2. Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML;
  • Serum total bilirubin ≤ 1.5 times the upper limit of normal, serum ALT and AST both ≤ 2.5 times the upper limit of the normal range, serum creatinine ≤ 1.5 times the upper limit of normal;
  • Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status score of 0-2.

Exclusion Criteria:

  • The subject's prior anti-tumor treatment history meets one of the following conditions:

    1. Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;
    2. Previously received doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin > 360 mg/m² (other anthracycline drugs are converted at a ratio of 1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);

  • Cardiac function and disease meet any of the following conditions:

    1. Long QTc syndrome or QTc interval > 480 ms;
    2. Complete left bundle branch block, second-degree or third-degree atrioventricular block;
    3. Severe, uncontrolled arrhythmia requiring medication;
    4. New York Heart Association (NYHA) classification ≥ Class II;
    5. Ejection fraction (EF) < 50% or below the lower limit of normal for the study center's laboratory;
    6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinically significant pericardial disease, or evidence on electrocardiogram of acute ischemia or active conduction system abnormalities within 6 months prior to enrollment.
  • Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug;
  • Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.);
  • Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast/cervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years);
  • Active hepatitis B or C infection during the viremic phase (Hepatitis B testing: if either HBsAg or core antibody is positive, add HBV-DNA testing; viral DNA levels exceeding 1x10^3 copies/mL; Hepatitis C testing: if HCV antibody is positive, add HCV-RNA testing; viral RNA levels exceeding 1x10^3 copies/mL);
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
  • Pregnant women, breastfeeding women, patients who refuse to use effective contraception during the study period;
  • Significant neurological or psychiatric history;
  • Patients deemed unsuitable for participation in this study by the investigator.

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: N/A
  • Interventional Model: Single Group 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: DCMG
Patients are treated with DCMG chemotherapy regimen.
Drug: Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF

The specific administration times and dosages for the DCMG chemotherapy regimen are as follows:

M: Mitoxantrone Hydrochloride Liposome Injection: 15 mg/m², IV, on Day 1, every 4 weeks (q4w); D: Decitabine: 20 mg/m², IV, Days 1-5, q4w; (or Azacitidine: 75 mg/m², IV, Days 1-7, q4w); C: Cytarabine: 100 mg, IV, every 12 hours on Days 1-5, q4w; For patients with hypoplastic bone marrow, the dose of cytarabine injection is 10 mg, every 12 hours, q4w; G: G-CSF: 5 μg/kg, subcutaneous injection, from Day 0 until the white blood cell count exceeds 10.0×10^9/L, at which point chemotherapy is stopped; or Pegylated Recombinant Human Granulocyte Stimulating Factor Injection: 100 μg/kg, subcutaneous injection, on Day 0.

One cycle lasts for 4 weeks, with a planned administration of 1 or 2 cycles.

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
Complete remission rate
Time Frame: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
At the end of Cycle 2 (each cycle is 28 days)

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
Relapse-Free Survival
Time Frame: 24 months
Time interval from leukemia free state to the first recurrence or death
24 months
Overall Survival
Time Frame: 24 months
Time interval from start of treatment until death or last follow-up
24 months
Duration of response
Time Frame: Time interval from morphologic/MRD response to loss of response or death
Time interval from morphologic/MRD response to loss of response or death
Adverse events
Time Frame: Start of treatment to 2 weeks after end of treatment
Number of subjects with each adverse event.
Start of treatment to 2 weeks after end of treatment

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.
Beijing 302 Hospital

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 (Actual)

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.
October 31, 2024

Primary Completion (Estimated)

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.
October 31, 2026

Study Completion (Estimated)

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, 2027

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).
December 9, 2024

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.
December 15, 2024

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.
March 25, 2025

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.
March 25, 2025

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.
December 20, 2024

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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • AML_DCMG_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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