This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Outcome in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700544
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : June 18, 2008
Sponsor:
Collaborators:
French Innovative Leukemia Organisation
BGMT
Information provided by:
University Hospital, Grenoble

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
AML Elderly Patients Drug: chemotherapy treatment (see arm) + norethandrolone Drug: chemotherapy treatment (see arms) Phase 3

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The primary objective of this study was to assess the ability of androgens to increase DFS. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy [ Time Frame: 3 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700544


Locations
Layout table for location information
France
Arnaud PIGNEUX
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Grenoble
French Innovative Leukemia Organisation
BGMT
Investigators
Layout table for investigator information
Principal Investigator: Jean jacques SOTTO, MD GOELAMS/BGMT
Principal Investigator: Arnaud PIGNEUX, MS GOELAMS/BGMT
Principal Investigator: Francis WITZ, MS French Innovative Leukemia Organisation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT
ClinicalTrials.gov Identifier: NCT00700544    
Other Study ID Numbers: LAM SA 2002
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: June 2008
Keywords provided by University Hospital, Grenoble:
AML
elderly patients
Treatment outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Norethandrolone
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs