Evaluating a new chemotherapy regimen for relapsed or refractory AML

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

This study is testing a new combination of chemotherapy drugs to see if it can help people with acute myeloid leukemia that hasn't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, doxorubicin
• Locations: 1 site (Beijing)
• Trial ID: NCT06741722 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a novel chemotherapy regimen called DCMG, which includes decitabine, azacitidine, mitoxantrone liposome, cytarabine, and G-CSF, for patients with relapsed or refractory acute myeloid leukemia (AML). The study aims to assess how well this combination therapy works in treating AML that has not responded to previous treatments. Participants will be closely monitored for both the effectiveness of the treatment and any potential side effects. The trial is designed to provide insights into a new approach for managing this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of relapsed or refractory AML.

Not a fit: Patients with severe comorbidities or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with relapsed or refractory AML.

How similar studies have performed: Other studies have explored similar chemotherapy regimens for AML, showing promising results, but this specific combination is novel.

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):

  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.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Dr. Gao Xiaoning, Chief Physician, Professor

Conditions AML; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; mitoxantrone liposome; Acute Myeloid Leukemia; relapsed/refractory AML; DCMG chemotherapy