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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

Conditions
High-risk (Secondary) Acute Myeloid Leukemia
Interventions
DRUG

Liposomal cytarabine-daunorubicin for injection

First induction: 100 units/m\^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m\^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m\^2 by 90-minute IV infusion on Days 1 and 3.

DRUG

7+3 (cytarabine and daunorubicin)

"First induction: 7+3 will be administered as: cytarabine at a dose of 100 mg/m\^2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m\^2/day on Days 1, 2, and 3.~Second induction: 5+2 will be administered as: cytarabine at a dose of 100 mg/m\^2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m\^2/day on Days 1 and 2.~Consolidation therapy: 5+2 will be administered as: cytarabine at a dose of 100 mg/m\^2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m\^2/day on Days 1 and 2."

Trial Locations (1)

Unknown

Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Tianjin

All Listed Sponsors
lead

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

INDUSTRY