NCT00700544

Treatment Outcome in Elderly Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• AML
• Elderly Patients

Interventions

Type	Name	Description
DRUG	chemotherapy treatment (see arm) + norethandrolone	oral form Dosage: 10 mg in patients with a weight \< 60 kgs 20 mg in patients with a weight \> 60 kgs frequency: every day Duration: 2 years
DRUG	chemotherapy treatment (see arms)	Induction chemotherapy + maintenance chemotherapy

Timeline

• Start date: 2002-06-01
• Primary completion: 2005-04-01
• Completion: 2008-05-01
• First posted: 2008-06-18
• Last updated: 2008-06-18

Locations

1 site across 1 country: France