NCT00915252

Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Randomized, Multi-center Phase II Trial to Assess the Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	azacitidine	Starting dose has been determined during run-in dose finding part of the study. Starting dose of the interventional drug is 75 mg/m²/d. Application form: During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles). During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy.
DRUG	standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine	Induction therapy: Daunorubicin 60mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7 Consolidation therapy: AraC 1g/m² twice a day on day 1,3,5

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-06-05
• Last updated: 2012-12-17

Locations

27 sites across 1 country: Germany