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OpenTrials
Completed

NCT Number: NCT00700544

Treatment Outcome in Elderly Patients

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

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Key information

Conditions

AML Elderly Patients

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arnaud PIGNEUX

Pessac, 33604, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chemotherapy treatment (see arm) + norethandrolone

Drug

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®

chemotherapy treatment (see arms)

Drug

Induction chemotherapy + maintenance chemotherapy

Other names: Induction chemotherapy + maintenance chemotherapy

Primary outcomes

  1. The primary objective of this study was to assess the ability of androgens to increase DFS.

    Time frame: 3 years

Secondary outcomes

  1. The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • BGMT
  • French Innovative Leukemia Organisation

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2008
First posted
Jun 18, 2008
Registry last updated
Jun 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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