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A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia
Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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.
Official title: A Randomized, Multi-center, Open-label Phase III Bridging Study to Compare Efficacy of Liposomal Cytarabine-Daunorubicin for Injection With Cytarabine and Daunorubicin in Treating Older Patients With High-Risk (Secondary) Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
60 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-01
Completion Date
2026-08
Last Updated
2023-12-28
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
Tianjin, China