Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 12, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

D-CMG

"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regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study."

Trial Locations (1)

361000

RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

All Listed Sponsors
lead

The First Affiliated Hospital of Xiamen University

OTHER