drugset / Trial / NCT00700544
Treatment Outcome in Elderly Patients
Phase 3
Completed
330 enrolled
University Hospital, Grenoble
BGMT · collabFrench Innovative Leukemia Organisation · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2002-06
- Primary completion
- 2005-04
- Completion
- 2008-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | norethandrolone | Small molecule | 10 mg | Oral |
| Subject | norethandrolone | Small molecule | 20 mg | Oral |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Background | Idarubicin | Small molecule | 8 mg/m2 | — |
| Background | Lomustine | Small molecule | 200 mg/m2 | — |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |