Treatment Outcome in Elderly Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700544

Enrollment

330

Registered

2008-06-18

Start date

2002-06-30

Completion date

2008-05-31

Last updated

2008-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, Elderly Patients

Keywords

AML, elderly patients, Treatment outcome

Brief 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

Detailed description

* 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

Interventions

DRUGchemotherapy 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

DRUGchemotherapy treatment (see arms)

Induction chemotherapy + maintenance chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary objective of this study was to assess the ability of androgens to increase DFS.	3 years

Secondary

Measure	Time frame
The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy	3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026