Treatment Outcome in Elderly Patients

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: BGMT; French Innovative Leukemia Organisation
• Treatments: 6-Mercaptopurine; Norethandrolone

Criteria

Inclusion Criteria:

• Patients aged 60 years or more

• "de novo" AML according to FAB criteria

• AML with 20% or more myeloid marrow blasts

• signed and dated informed consent

• OMS score < 3

• Life expectancy > 1 month

Exclusion Criteria:

• Patients aged < 60 years

• or AML M3

• or not classificated according to FAB criteria

• or extramedular localisation of AML

• OMS score ≥ 3

• clinical Abnormal Cardiac fonction or with left ejection fraction < 40 %

• abnormal renal function with creatinine clearance < 50/ml/mn/m²

• abnormal hepatic function

• previous cerebral stroke

• previous malignancy : prostate, breast cancer (males)

• PSA dosage > 4

• Any coexisting medical or psychological condition that would pleclude participation in the required study procedures