NCT00822094

Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CPX-351
DRUG	Intensive Salvage Therapy

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2009-01-14
• Last updated: 2017-11-24
• Results posted: 2017-09-29

Locations

42 sites across 4 countries: United States, Canada, France, Poland