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

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 25, 2023

Primary Completion Date

April 30, 2025

Study Completion Date

December 31, 2025

Conditions
Acute Myeloid Leukemia
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

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