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

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: Recruiting
• Conditions: AML; Refractory Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia
• Intervention / Treatment: Drug: Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: 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: Lei Xu; Phone Number: 86-01066947174; Email: xulei800@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Complete remission rate	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

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

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; AML; relapsed/refractory AML; mitoxantrone liposome; DCMG chemotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Sensory System Agents; Antiviral Agents; Analgesics; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Decitabine; Cytarabine; Azacitidine; Mitoxantrone
• Other Study ID 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