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Acute Myeloid LeukemiaPhase 3ALFA 9801NCT00931138

Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2

A Phase 3 study testing chemotherapy (Aracytine + Daunorubicin) in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 16 sites in France.

Completed

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

Official record
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Trial summary

Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2 Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
chemotherapy (Aracytine + Daunorubicin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
16 sitesFrance
Study dates
Dec 1999to Dec 2006
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 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient from 50 to 70 years
  • AML de Novo
  • No prior therapy for AML
  • Absence of severe infection (WHO grade greater than 2), independent of the AML
  • Cardiac function determined by radionucleotide or echography within normal limits.
  • total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N
  • ECOG performance status 0 to 3
  • Signed informed consent.

Who cannot join

  • M3-AML
  • history of neoplasia treated by radiotherapy or chemotherapy
  • Myelodysplasia diagnosed more than 6 months before the diagnosis of AML
  • Prior treatment for AML
  • Uncontrolled infection
  • Other active malignancy
  • Patient unable to undergo regular surveillance

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CH

    Caen, 14033

  • Hopital Percy

    Clamart, 92141

  • CHU

    Créteil, 94010

  • CH

    Lens, 62307

  • CHU

    Lille, 59037

  • CH

    Limoges, 87042

  • Hopital Edouard Herriot

    Lyon

  • St Antoine Hospital

    Paris, 75012

  • Hopital Pitie-Salpetriere

    Paris, 75651

  • Hopital Saint-Louis

    Paris

  • CH

    Roubaix, 59100

  • CHU

    Rouen, 76038

  • CNLCC

    Saint-Cloud, 92210

  • CH

    Valenciennes, 59322

  • CH

    Versailles

  • IGR

    Villejuif, 94805

Other trials in France

About this study

Official title: Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801

Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

Read the detailed description

Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.

Being tested
chemotherapy (Aracytine + Daunorubicin)
Keywords
Acute Myeloid Leukemia in adults, Newly-diagnosed untreated AML, Patient aged 50 to 70 years
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • chemotherapy (Aracytine + Daunorubicin)Drug

    Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3

  • chemotherapy (Aracytine + Daunorubicin)Drug

    Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3

  • chemotherapy (Aracytine + Daunorubicin)Drug

    Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4

Study groups in NCT00931138
Study groupRoleWhat they receive
Arm1 = Aracytine + DaunorubicinActive comparatorAracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Receives: Drug: chemotherapy (Aracytine + Daunorubicin)
Arm 3 = Aracytine And IdarubicinActive comparatorAracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Receives: Drug: chemotherapy (Aracytine + Daunorubicin)
Arm 2 = Aracytine And IdarubicinActive comparatorAracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Receives: Drug: chemotherapy (Aracytine + Daunorubicin)

What is being measured

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

  1. To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin

Secondary outcomes (1)

  1. Frequency and severity of adverse events

Timeline

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

  1. First posted2 Jul 2009 (estimated)
  2. Study startDec 1999
  3. Study completionDec 2006

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
420 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931138
Sponsor's protocol ID
ALFA 9801
Acronym
ALFA 9801
Status last verified
Aug 1999
First submitted
29 Jun 2009
Last updated
2 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terre C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.

    PubMed 23749683

  • Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terre C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

    PubMed 23248249

  • Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terre C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

    PubMed 21459791

  • Boissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.

    PubMed 20625116

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy (Aracytine + Daunorubicin) in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 16 sites 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 8 inclusion and 7 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 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin. 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 NCT00931138, which also lists 4 linked publications.

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 2 Jul 2009.

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