NCT05801835

A Bioequivalence Study of (Cytarabine: Daunorubicin) Liposome for Injection

A Randomized, Open-label, Two-period, Two-way Crossover Bioequivalence Study of Two (Cytarabine: Daunorubicin) Liposome for Injection in Elderly AML Subjects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the bioequivalence of (cytarabine: daunorubicin) liposome for injection and Vyxeos in elderly acute myeloid leukemia (AML) subjects.

Detailed description

This is a multi-center, randomized, open-label, two-period, two-sequence, two-way crossover bioequivalence study of (cytarabine: daunorubicin) liposome for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd compared with Vyxeos manufactured by Jazz Pharmaceuticals, Inc. in elderly AML subjects. Patients who have achieved CR/CRi after induction treatment will be randomized to sequence A (T-R): (cytarabine: daunorubicin) liposome on C1D1 and C1D3/ Vyxeos on C2D1 and C2D3 or sequence B(R-T): Vyxeos on C1D1 and C1D3/ (cytarabine: daunorubicin) liposome on C2D1 and C2D3. Randomization will be in a 1:1 ratio. Forty to sixty subjects will be enrolled to ensure 36 evaluable subjects. Serial blood samples for determination of liposomal encapsulated cytarabine and liposomal encapsulated daunorubicin plasma concentration for PK analysis will be obtained in each cycle.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	(cytarabine: daunorubicin) liposome for injection	Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.
DRUG	Vyxeos	Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.
DRUG	(cytarabine: daunorubicin) liposome for injection	Be given intravenously at 65U/m\^2 on days 1 and day3 of the second cycle of induction.
DRUG	Vyxeos	Be given intravenously at 65U/m\^2 on days 1 and day3 of the second cycle of induction.

Timeline

• Start date: 2023-08-25
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2023-04-06
• Last updated: 2023-09-21

Locations

1 site across 1 country: China