drugset / Trial / NCT06741722

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

NCT06741722

Phase 2 Recruiting 20 enrolled Beijing 302 Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-10-31
Primary completion
2026-10-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Cytarabine Small molecule 10 mg Intravenous
Subject Cytarabine Small molecule 100 mg Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Background Mitoxantrone Small molecule 15 mg/m2 Intravenous
Background Pegylated Recombinant Human Granulocyte Stimulating Factor Protein / enzyme biologic 100 ug/kg Subcutaneous