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

Official title

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

Overview

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.

Interventions

• 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 Da

Primary outcome measures

• Complete remission rate [Time frame: At the end of Cycle 2 (each cycle is 28 days)]

Secondary outcome measures (4)

• Relapse-Free Survival [Time frame: 24 months]
• Overall Survival [Time frame: 24 months]
• Duration of response [Time frame: 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]

Eligibility criteria

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):

• Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;
• 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:

• Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;
• 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:

• Long QTc syndrome or QTc interval > 480 ms;
• Complete left bundle branch block, second-degree or third-degree atrioventricular block;
• Severe, uncontrolled arrhythmia requiring medication;
• New York Heart Association (NYHA) classification ≥ Class II;
• Ejection fraction (EF) < 50% or below the lower limit of normal for the study center's laboratory;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT06741722 · AML_DCMG_2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗