Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-13
Brief Title:
A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk Secondary Acute Myeloid Leukemia
Sponsor:
CSPC Zhongnuo Pharmaceutical Shijiazhuang Co Ltd
Organization:
CSPC Zhongnuo Pharmaceutical Shijiazhuang Co Ltd
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 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
Detailed Description:
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 cytarabinedaunorubicin 73 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 11 ratio to receive liposomal cytarabine-daunorubicin or daunorubicincytarabine 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 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?:
None