Treatment Outcome in Elderly Patients

Phase 3

Completed

• Conditions: AML; Elderly Patients
• Interventions: Drug: chemotherapy treatment (see arm) + norethandrolone; Drug: chemotherapy treatment (see arms)

• Registration Number: NCT00700544
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2005-04
• Study Completion: 2008-05
• Status Verified: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Last Update Submitted: 2008-06-13
• Study First Posted: 2008-06-18
• Last Update Posted: 2008-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	chemotherapy treatment (see arm) + norethandrolone	* 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.
B	chemotherapy treatment (see arms)	* 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arnaud PIGNEUX; 🇫🇷 Pessac, France