NCT00788892

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CPX-351
DRUG	Cytarabine
DRUG	Daunorubicin

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-06-01
• Completion: 2011-12-01
• First posted: 2008-11-11
• Last updated: 2018-01-12
• Results posted: 2018-01-12

Locations

28 sites across 2 countries: United States, Canada