RecruitingPhase 2NCT06741722

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

Sponsor

Beijing 302 Hospital

Enrollment

20 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

AML Refractory Acute Myeloid Leukemia Relapsed Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy combination — mitoxantrone hydrochloride liposome with cytarabine, midostaurin, and G-CSF (the DCMG regimen) — for patients with relapsed or refractory acute myeloid leukemia (AML), a fast-growing blood cancer that has come back or stopped responding to previous treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with AML that has relapsed (came back) or is refractory (did not respond to initial treatment) - Your liver, kidney, and cardiac function are within acceptable limits - You have signed an informed consent form **You may NOT be eligible if...** - You have never been treated for AML (this is for relapsed/refractory cases) - You have severe organ dysfunction (liver, kidney, or heart) - You have conditions that make the DCMG chemotherapy regimen unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDecitabine, 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.