NCT00700544

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

June 18, 2008

Status Verified

June 1, 2008

Enrollment Period

2.8 years

First QC Date

June 13, 2008

Last Update Submit

June 13, 2008

Conditions

AMLElderly Patients

Keywords

AMLelderly patientsTreatment outcome

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study was to assess the ability of androgens to increase DFS.

    3 years

Secondary Outcomes (1)

  • The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy

    3 years

Study Arms (2)

B

ACTIVE COMPARATOR

* 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)

A

EXPERIMENTAL

* 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

Interventions

chemotherapy treatment (see arm) + norethandroloneDRUG

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

Also known as: norethandrolone = nilevar®
A
chemotherapy treatment (see arms)DRUG

Induction chemotherapy + maintenance chemotherapy

Also known as: Induction chemotherapy + maintenance chemotherapy
B

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arnaud PIGNEUX

Pessac, 33604, France

Location

Related Publications (1)

  • Pigneux A, Bene MC, Guardiola P, Recher C, Hamel JF, Sauvezie M, Harousseau JL, Tournilhac O, Witz F, Berthou C, Escoffre-Barbe M, Guyotat D, Fegueux N, Himberlin C, Hunault M, Delain M, Lioure B, Jourdan E, Bauduer F, Dreyfus F, Cahn JY, Sotto JJ, Ifrah N. Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study. J Clin Oncol. 2017 Feb;35(4):387-393. doi: 10.1200/JCO.2016.67.6213. Epub 2016 Oct 24.

    PMID: 28129526DERIVED

MeSH Terms

Interventions

NorethandroloneInduction ChemotherapyMaintenance Chemotherapy

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug TherapyTherapeuticsRemission Induction

Study Officials

  • Jean jacques SOTTO, MD

    GOELAMS/BGMT

    PRINCIPAL INVESTIGATOR

  • Arnaud PIGNEUX, MS

    GOELAMS/BGMT

    PRINCIPAL INVESTIGATOR

  • Francis WITZ, MS

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

June 1, 2002

Primary Completion

April 1, 2005

Study Completion

May 1, 2008

Last Updated

June 18, 2008

Record last verified: 2008-06

Locations

FR(1)