Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 12:05 AM
Study NCT ID:
NCT05801835
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of (Cytarabine: Daunorubicin) Liposome for Injection
Sponsor:
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Two-period, Two-way Crossover Bioequivalence Study of Two (Cytarabine: Daunorubicin) Liposome for Injection in Elderly AML Subjects
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Serial blood samples for determination of liposomal encapsulated cytarabine and liposomal encapsulated daunorubicin plasma concentration for PK analysis will be obtained in each cycle.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: