Trial | NCT00700544  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    330
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 Started
Jun 30
2002
Primary Completion
Apr 30
2005
Study Completion
May 31
2008
Last Update
Jun 18
2008
Estimate

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

  • Other names: norethandrolone = nilevar®

Drug chemotherapy treatment (see arms)

Induction chemotherapy + maintenance chemotherapy

  • Other names: Induction chemotherapy + maintenance chemotherapy

B Active Comparator

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.

A Experimental

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.

Criteria 

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
No Results Posted