Treatment Outcome in Elderly Patients

June 13, 2008 updated by: University Hospital, Grenoble

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • Arnaud PIGNEUX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • norethandrolone = nilevar®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study was to assess the ability of androgens to increase DFS.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

French Innovative Leukemia Organisation
BGMT

Investigators

  • Principal Investigator: Jean jacques SOTTO, MD, GOELAMS/BGMT
  • Principal Investigator: Arnaud PIGNEUX, MS, GOELAMS/BGMT
  • Principal Investigator: Francis WITZ, MS, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 18, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM SA 2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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