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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2027

Conditions
AMLRelapsed Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
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 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."

Trial Locations (1)

Unknown

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Beijing 302 Hospital

OTHER