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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Chinese PLA General Hospital
Beijing, China
RECRUITINGComplete remission rate
Percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Relapse-Free Survival
Time interval from leukemia free state to the first recurrence or death
Time frame: 24 months
Overall Survival
Time interval from start of treatment until death or last follow-up
Time frame: 24 months
Duration of response
Time frame: Time interval from morphologic/MRD response to loss of response or death
Adverse events
Number of subjects with each adverse event.
Time frame: Start of treatment to 2 weeks after end of treatment
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