to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes. * Level 1: 12mg/m2, IV drip, day 4; * Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle. Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGMaximum tolerated dose (MTD)
Defined as the highest dose at which less than 2 out of 6 (ie. 33%) participants experience a Dose-Limiting Toxicity (DLT).
Time frame: Up to 24 months
Complete Response Rate (CR)
The percent of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML)
Time frame: Up to 24 months
Complete Response with incomplete blood count recovery (CRi)
Meets all CR criteria, except for residual neutropenia \< 1,000/µL or hrombocytopenia \< 100,000/µL. Dependence on red blood cell (RBC) transfusions is also defined as CRi.
Time frame: Up to 24 months
Disease free survival (DFS)
Applies only to patients who achieve CR or CRi. It is measured from the date of remission to the date of relapse or death from any cause.
Time frame: Up to 24 months
Overall survival (OS)
Time from the start of the patient's initial treatment to the time of death due to any cause.
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.