AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.

NCT00180102 Phase 4 COMPLETED

AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.

Details

Lead sponsor	Technische Universität Dresden
Phase	Phase 4
Status	COMPLETED
Enrolment	600
Start date	2003-12
Completion	2009-11

Conditions

• Leukemia, Nonlymphocytic, Acute

Interventions

• Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone
• early allogeneic PBSCT within induction therapy
• autologous PBSCT

Primary outcomes

• overall survival
• relapse-free survival

Countries

Germany