Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00788892
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.
Status:
COMPLETED
Status Verified Date:
2017-10
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 study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.
The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.
The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.
Detailed Description:
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: