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.
Liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd is a class 3 chemical drug imitating Vyxeos developed by Jazz Pharmaceuticals plc. This bridging trial compares the efficacy of liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd with cytarabine/daunorubicin (7+3) in elderly patients with treatment-naïve high-risk (secondary) AML to determine that test drug is comparable to Vyxeos in efficacy, safety and pharmacokinetic properties. Patients will be randomized in a 1:1 ratio to receive liposomal cytarabine-daunorubicin or daunorubicin/cytarabine as induction and consolidation chemotherapy. Patients will receive up to two cycles of induction and consolidation therapy. After the treatment period, there is a follow-up phase for overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
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.
Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
Tianjin, China
Overall Survival (OS)
Overall survival will be measured from the date of randomization to death from any cause.
Time frame: Up to 2 years
Event-free survival (EFS)
EFS is defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from complete remission (CR) or complete remission with incomplete count recovery (CRi) or death from any cause, whichever occurs first.
Time frame: Up to 2 years
Duration of remission (DoR)
DoR is defined as the time from the day achieving CR or CRi to the date of relapse or death. Only patients achieving CR or CRi will be assessed for remission duration.
Time frame: Up to 2 years
CR rate
Proportion of patients with complete remission during the treatment period.
Time frame: Up to 2 years
Composite remission rate
Proportion of patients with CR or CRi.
Time frame: Up to 2 years
Proportion of patients receiving a haematopoietic stem cell transplant (HSCT)
The number and percentage of patient transferred for HSCT after induction treatment will be recorded.
Time frame: Up to 2 years
Proportion of pateints who achieve CR with MRD negativity
The number and percentage of patients who are MRD negative.
Time frame: Up to 2 years
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