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AzTrials

Acute Myeloid LeukemiaPhase 3NCT00927498

A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

A Phase 3 study testing conventional chemotherapy (AraC + Daunorubicin), and Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 19 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

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses. 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?
conventional chemotherapy (AraC + Daunorubicin), and Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
19 sitesFrance
Study dates
Dec 2007to Jul 2013
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

  • Patients with a morphologically proven diagnosis AML and both the two following criteria: Age > 50 years and £ 70 years. Not previously treated for their disease.
  • ECOG performance status 0 to 3
  • Negative serology HIV, HBV and HBC (except post vaccination)
  • Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N
  • Cardiac function determined by radionucleide or echography within normal limits.
  • Negative serum pregnancy test within one week before treatment for women of child bearing potential.
  • Signed informed consent.

Who cannot join

  • M3-AML
  • AML following previously know myeloproliferative syndrome.
  • Known central nervous system involvement.
  • Uncontrolled infection
  • Other active malignancy

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CH

    Argenteuil, 95107

  • Hopital Avicenne

    Bobigny, 93309

  • CH

    Caen, 14033

  • Hopital Percy

    Clamart, 92141

  • CHU

    Créteil, 94010

  • CHU

    Dijon, 21034

  • CH

    Lens, 62307

  • CHU

    Lille, 59037

  • CH

    Limoges, 87042

  • Hopital Edouard Herriot

    Lyon, 69437

  • CH

    Meaux, 77104

  • Hopital Pitie-Salpetriere

    Paris, 75651

  • Hopital Saint-Louis

    Paris

  • CH

    Roubaix, 59100

  • CHU

    Rouen, 76038

  • CNLCC

    Saint-Cloud, 92210

  • CH

    Valenciennes, 59322

  • Hospital Central

    Versailles, 78157

  • IGR

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

Read the detailed description

Patients with a morphologically proven diagnosis AML and both the two following criteria:

  • Age > 50 years and £ 70 years.
  • Not previously treated for their disease.

Randomization will be centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Being tested
conventional chemotherapy (AraC + Daunorubicin),, Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
Keywords
Acute myeloid Leukemia, 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.

  • conventional chemotherapy (AraC + Daunorubicin),Drug

    Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

    Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

  • Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),Drug

    Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

    Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

    Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.

Study groups in NCT00927498
Study groupRoleWhat they receive
Arm A Daunorubicin and CytarabineActive comparatorDaunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
Receives: Drug: conventional chemotherapy (AraC + Daunorubicin),
Arm B Daunorubicin and Cytarabine and MylotargExperimentalDaunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4. Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.
Receives: Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),

What is being measured

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

  1. Event Free Survival (EFS)

    Measured: Relapse or death measured from randomization

Secondary outcomes (6)

  1. CR rate

    Measured: CR after induction

  2. Cumulative incidence of relapse

    Measured: Relapse from CR

  3. Overall Survival

    Measured: Survival from randomization

  4. Safety of the combination Mylotarg+chemotherapy

    Measured: Duration of study

  5. Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)

    Measured: Duration of study

  6. Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.

    Measured: Duration of study

Timeline

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

  1. First posted25 Jun 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2011
  4. Study completionJul 2013

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
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00927498
Sponsor's protocol ID
ALFA 0701
Status last verified
Jul 2013
First submitted
29 Apr 2009
Last updated
11 Jul 2013
Results posted
No

Publications

  • Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.

    PubMed 33858190

  • Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Dulery R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32. doi: 10.18632/oncotarget.1536.

    PubMed 24659740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing conventional chemotherapy (AraC + Daunorubicin), and Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 19 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 7 inclusion and 5 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Event Free Survival (EFS) (time frame: Relapse or death measured from randomization). 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 NCT00927498, which also lists 2 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 11 Jul 2013.

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