NCT01074047

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
DRUG	Conventional Care Regimen	Physician pre-selects prior to randomization from one of the following: * Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles * Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity * Best Supportive Care only; until study end

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-01-22
• Completion: 2016-07-25
• First posted: 2010-02-24
• Last updated: 2017-08-29
• Results posted: 2015-02-26

Locations

112 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study