AzTrials
AzTrials

AMLPhase 3NCT00700544

Treatment Outcome in Elderly Patients

A Phase 3 study testing chemotherapy treatment (see arm) + norethandrolone and chemotherapy treatment (see arms) in people with AML and Elderly Patients, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
AML, Elderly Patients
What is being tested?
chemotherapy treatment (see arm) + norethandrolone and chemotherapy treatment (see arms)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteFrance
Study dates
Jun 2002to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 %
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Arnaud PIGNEUX

    Pessac, 33604

Other trials in France

About this study

Official title: 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

Read the 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
Being tested
chemotherapy treatment (see arm) + norethandrolone, chemotherapy treatment (see arms)
Keywords
AML, elderly patients, Treatment outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapy treatment (see arm) + norethandroloneDrug

    Also called norethandrolone = nilevar®

    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

  • chemotherapy treatment (see arms)Drug

    Also called Induction chemotherapy + maintenance chemotherapy

    Induction chemotherapy + maintenance chemotherapy

Study groups in NCT00700544
Study groupRoleWhat they receive
BActive 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.
Receives: Drug: chemotherapy treatment (see arms)
AExperimental* 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.
Receives: Drug: chemotherapy treatment (see arm) + norethandrolone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

Secondary outcomes (1)

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2008 (estimated)
  2. Study startJun 2002
  3. Primary completionApr 2005
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00700544
Sponsor's protocol ID
LAM SA 2002
Status last verified
Jun 2008
First submitted
13 Jun 2008
Last updated
18 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28129526

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy treatment (see arm) + norethandrolone and chemotherapy treatment (see arms) in people with AML and Elderly Patients, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study was to assess the ability of androgens to increase DFS. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00700544, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in