Treatment Outcome in Elderly Patients

University Hospital, Grenoble330 enrolled

Overview

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: * 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

AML Elderly Patients

Interventions

chemotherapy treatment (see arm) + norethandroloneDRUG

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

chemotherapy treatment (see arms)DRUG

Induction chemotherapy + maintenance chemotherapy

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Arnaud PIGNEUX

Pessac, France

Outcomes

Primary Outcomes

The primary objective of this study was to assess the ability of androgens to increase DFS.

Time frame: 3 years

Secondary Outcomes

The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy

Time frame: 3 years

Data from ClinicalTrials.gov

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