Treatment Outcome in Elderly Patients

AML Clinical Trial

Official title: Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.

Status Completed

Clinical Trial Summary

A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years

Clinical Trial Description

• Induction Therapy:

• Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1

• if CR or PR: randomisation = maintenance therapy including or not androgens

• Maintenance therapy :

• 6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.

• Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Elderly Patients

• NCT number: NCT00700544
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Completed
• Phase: Phase 3
• Start date: June 2002
• Completion date: May 2008