Treatment Outcome in Elderly Patients

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: AML; Elderly Patients

Treatments: Drug: chemotherapy treatment (see arm) + norethandrolone; Drug: chemotherapy treatment (see arms)

Study type: Interventional

Funder types: Other

Identifiers

NCT00700544

LAM SA 2002

Details and patient eligibility

About

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

Full 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

Enrollment: 330 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

B

Active Comparator group

Description:

* 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.

Treatment:

Drug: chemotherapy treatment (see arms)

A

Experimental group

Description:

* 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.

Treatment:

Drug: chemotherapy treatment (see arm) + norethandrolone