Treatment Outcome in Elderly Patients

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700544
• Other study ID #: LAM SA 2002
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2008
• Last updated: June 13, 2008
• Start date: June 2002
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 2008
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Elderly Patients

Intervention

Drug:
• chemotherapy 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
• chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy

Locations

Country	Name	City	State
France	Arnaud PIGNEUX	Pessac

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	BGMT, Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study was to assess the ability of androgens to increase DFS.		3 years	Yes
Secondary	The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy		3 years	Yes