Treatment Outcome in Elderly Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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AML, Elderly Patients

Intervention / Treatment
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* Drug: chemotherapy treatment (see arm) + norethandrolone
* Drug: chemotherapy treatment (see arms)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>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)<br>* Induction chemotherapy + maintenance chemotherapy<br>* Other names: Induction chemotherapy + maintenance chemotherapy;|
| Experimental: A<br>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<br>* 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<br>* Other names: norethandrolone = nilevar®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to assess the ability of androgens to increase DFS. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, elderly patients, Treatment outcome