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Treatment Outcome in Elderly Patients

NCT00700544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2008-06-18

No results posted yet for this study

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

Conditions

  • AML
  • Elderly Patients

Interventions

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

DRUG

chemotherapy treatment (see arms)

Induction chemotherapy + maintenance chemotherapy

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    collaborator OTHER

  • BGMT

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean jacques SOTTO, MD · GOELAMS/BGMT

  • Arnaud PIGNEUX, MS · GOELAMS/BGMT

  • Francis WITZ, MS · French Innovative Leukemia Organisation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2005-04-30
Completion
2008-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700544 on ClinicalTrials.gov