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Patients are eligible to receive up to 2 inductions and up to 2 consolidations with liposomal cytarabine-daunorubicin for injection. The number of inductions and consolidations a patient received will depend on response.

Patients are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7+3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received will depend on response.

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.

Liposomal cytarabine-daunorubicin for injection

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.

7+3 (cytarabine and daunorubicin)

Clinical Trials Information Group officer

Jianxiang Wang

Jianxiang Wang, MD

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.

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

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

Overall survival will be measured from the date of randomization to death from any cause.

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.

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.

Proportion of patients with complete remission during the treatment period.

The number and percentage of patient transferred for HSCT after induction treatment will be recorded.

The number and percentage of patients who are MRD negative.

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.

First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.

CPX-351

First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.

Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.

Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.

To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.

Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.

All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.

Only subjects achieving CR or CRi were assessed for remission duration.

All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.

The number and percentage of subjects transferred for HSCT after induction treatment was recorded.

The Leukemia and Lymphoma Society

Jazz Pharmaceuticals

Safety Population: All randomized participants who received at least one dose of study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia	NCT06182592	High-risk (Seco...	Liposomal cytar... 7+3 (cytarabine...	60 Years - 75 Years	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia	NCT01696084	High Risk Acute...	CPX-351 7+3 (cytarabine...	60 Years - 75 Years	Jazz Pharmaceuticals
A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia	NCT06182592	High-risk (Seco...	Liposomal cytar... 7+3 (cytarabine...	60 Years - 75 Years	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Spots Global Cancer Trial Database for 7+3 (cytarabine and daunorubicin)