A Phase 3 interventional study of chemotherapy treatment (see arm) + norethandrolone and chemotherapy treatment (see arms) in AML and Elderly Patients, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2008-06-18.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
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
Induction Therapy:
Maintenance therapy :
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR * maintenance therapy every 3 months = 6 courses of reinduction with : -idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5 ), subcutaneously * between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
Drug: chemotherapy treatment (see arms)
* Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR * maintenance therapy every 3 months = 6 courses of reinduction with : * idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5, subcutaneously) * 10 to 20 mg (according to body weigh) of norethandrolone daily * between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
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
Also known as: norethandrolone = nilevar®
Induction chemotherapy + maintenance chemotherapy
Also known as: Induction chemotherapy + maintenance chemotherapy
The primary objective of this study was to assess the ability of androgens to increase DFS.
Time frame: 3 years
The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy
Time frame: 3 years
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble