drugset / Trial / NCT06182592

A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia

NCT06182592

Phase 3 Not yet recruiting 120 enrolled CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.

Timeline

Start
2024-01
Primary completion
2026-02
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 100 mg/m2 Intravenous
Subject Daunorubicin Small molecule 60 mg/m2
Subject Liposomal cytarabine-daunorubicin for injection Small molecule 100 unknown Intravenous