Treatment Outcome in Elderly Patients

This study has been completed.
Sponsor:
Collaborators:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
BGMT
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00700544
First received: June 13, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 13, 2008
June 13, 2008
June 2002
April 2005   (final data collection date for primary outcome measure)
The primary objective of this study was to assess the ability of androgens to increase DFS. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • AML
  • Elderly Patients
  • 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 Name: norethandrolone = nilevar®
  • Drug: chemotherapy treatment (see arms)
    Induction chemotherapy + maintenance chemotherapy
    Other Name: Induction chemotherapy + maintenance chemotherapy
  • Active Comparator: B
    • 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.
    Intervention: Drug: chemotherapy treatment (see arms)
  • Experimental: A
    • 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.
    Intervention: Drug: chemotherapy treatment (see arm) + norethandrolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
May 2008
April 2005   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00700544
LAM SA 2002
Yes
CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT
University Hospital, Grenoble
  • Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  • BGMT
Principal Investigator: Jean jacques SOTTO, MD GOELAMS/BGMT
Principal Investigator: Arnaud PIGNEUX, MS GOELAMS/BGMT
Principal Investigator: Francis WITZ, MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
University Hospital, Grenoble
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP