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
  Purpose

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


Condition Intervention Phase
AML
Elderly Patients
Drug: chemotherapy treatment (see arm) + norethandrolone
Drug: chemotherapy treatment (see arms)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 330
Study Start Date: June 2002
Study Completion Date: May 2008
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy
Other Name: Induction chemotherapy + maintenance chemotherapy
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.
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®

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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700544

Locations
France
Arnaud PIGNEUX
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Grenoble
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
BGMT
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT
ClinicalTrials.gov Identifier: NCT00700544     History of Changes
Other Study ID Numbers: LAM SA 2002
Study First Received: June 13, 2008
Last Updated: June 13, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Grenoble:
AML
elderly patients
Treatment outcome

Additional relevant MeSH terms:
Norethandrolone
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014