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

NCT06741722 | Recruiting Phase 2

• 1 other identifier: AML_DCMG_2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AML; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Relapse-Free Survival

  24 months

• Overall Survival

  24 months

• Duration of response

  Time interval from morphologic/MRD response to loss of response or death

• Adverse events

  Start of treatment to 2 weeks after end of treatment

Study Arms (1)

DCMG

EXPERIMENTAL

Patients are treated with DCMG chemotherapy regimen.

Drug: Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF

Interventions

Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF DRUG

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.

DCMG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Azacitidine; Cytarabine; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Dr. Gao Xiaoning, Chief Physician, Professor

CONTACT

86+01066947169; gaoxn@263.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 19, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)