Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 6:17 AM
Study NCT ID:
NCT00822094
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2009-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
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 intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.
The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
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 intensive first salvage treatment.
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:
False
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?: