Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
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.
Acute Myeloid Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ] [ Designated as safety issue: No ]
- Response Duration [ Time Frame: Following achievement of CR and up to 2 years from randomization ] [ Designated as safety issue: No ]
- Event Free Survival [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
- Survival at 2 years [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
- rate of stem cell transplant [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
- Early induction mortality at day 30 and at day 60 from start of 1st induction [ Time Frame: day 30 and day 60 from 1st induction ] [ Designated as safety issue: Yes ]
- Late mortality [ Time Frame: following Day 90 from 1st induction ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm A: CPX-351
CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5 as a 90 minute infusion
Active Comparator: Arm B: Cytarabine + Daunorubicin
"7 + 3" regimen
Cytarabine at a dose of 100mg/m2/day for 7 daysDrug: Daunorubicin
Daunorubicin at dose of 60mg/m2 for 3 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788892
Show 28 Study Locations
|Principal Investigator:||Jeffrey E Lancet, MD||H. Lee Moffitt Cancer Center|