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Acute Myeloid LeukemiaPhase 2/3ALFA1401NCT02473146

Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4

A Phase 2/3 study testing Gemtuzumab ozogamicin (GO) in people with Acute Myeloid Leukemia, run by Versailles Hospital at 21 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

Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Gemtuzumab ozogamicin (GO)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
21 sitesFrance
Study dates
18 Nov 2015to 7 Sep 2023
Phase
Phase 2/3
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 to 80 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 following criteria:
  • Age ≥ 60 years and < 80 years.
  • Not previously treated for their disease.
  • With favourable or intermediate-risk cytogenetics. (Patients with urgent clinical need to begin treatment might be included before cytogenetic results, when necessary if they do not respond to Hydroxyurea. Patients might be included if the cytogenetic results are not expected in a time limit < 5 days after AML diagnosis).
  • Fit to receive intensive chemotherapy
  • Cardiac function determined by radionucleide or echography within normal limits.
  • Signed informed consent

Who cannot join

  • M3-AML
  • Presence of adverse cytogenetics (according to European LeukemiaNet recommendation.) (17) defined as one of the following abnormalities: -5/5q-, -7, t(6;9), t(v;11q23) excluding t(9;11), inv(3)(q21;q26.2) or t(3;3)(q21;q26.2), complex karyotype (3+ abnormalities)
  • Secondary AML following treatment with radiotherapy or chemotherapy.
  • AML following previously known myeloproliferative or myelodysplastic syndrome.
  • ECOG performance status (PS) 0 to 3
  • Serum creatinin level > or = 2.5N; AST and ALT level > or = 2.5N; total bilirubin level > or = 2N

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • C.H.U d'Amiens - Hôpital Sud

    Amiens

  • Hôpital V. Dupouy

    Argenteuil

  • CH Avicenne

    Bobigny

  • CHU Caen

    Caen

  • HIA Percy

    Clamart, 92140

  • Hopital Henri Mondor

    Créteil

  • CHU Dijon

    Dijon

  • CH Dunkerque

    Dunkirk

  • CH Versailles

    Le Chesnay, 78157

  • Hôpital Huriez, CHU de Lille

    Lille

  • CHU Limoges

    Limoges

  • Hôpital de la Conception

    Marseille, 13005

  • Centre Antoine Lacassagne

    Nice, 06100

  • CHU d'Orléans

    Orléans, 45100

  • Hopital Necker

    Paris

  • Hopital St Louis

    Paris

  • Hôpital Saint Antoine

    Paris

  • CHU Lyon Sud

    Pierre-Bénite

  • Centre H Becquerel

    Rouen

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • IGR

    Villejuif

Other trials in France

About this study

Official title: Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable

Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.

Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.

Being tested
Gemtuzumab ozogamicin (GO)
Keywords
AML, untreated, 60-80 years old, favorable and intermediate karyotype
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.

  • Gemtuzumab ozogamicin (GO)Drug

    Also called Mylotarg

Study groups in NCT02473146
Study groupRoleWhat they receive
Mylotarg ArmExperimentalAfter randomization patients in the experimental arm are assigned to receive chemotherapy with: Gemtuzumab Ozogamicin 3 mg/m2 (maximum dose: 5 mg) per IV, 60mn on Day 1 and 4 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7
Receives: Drug: Gemtuzumab ozogamicin (GO)
Control ArmNo interventionAfter randomization patients in the control arm are assigned to receive chemotherapy with Idarubicin 12mg/m2 per IV, 30mn on Day 1,2,3 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7

What is being measured

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

  1. EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death)

    Endoint for the primary objective of efficacy is EFS defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death.

    Measured: 5 years

Secondary outcomes (2)

  1. Composite measure for Efficacy assessed by CR/Cri rates, cumulative incidence of relapse, overall survival.

    Measured: 5 years

  2. Composite measure for safety

    • incidence of early deaths < day 30 and day 60,
    • grade 3 to 5 adverse events and all serious adverse events during induction and consolidation treatment
    • cardiac toxicity evaluated on cardiac ejection function evaluation by echocardiography or isotopic measure.
    • Quality of life measured by questionaries' EORTC QLQ-C30 repeated at diagnosis, after induction treatment, after the two consolidations and 3 months after the end of treatment.

    End points for treatment-by-covariate interactions are

    • at diagnosis: percentage of CD33 positivity on blast cells, measured with a standardized method, cytogenetics and most relevant molecular markers (FLT3, MLL, CEBPa, NPM1, DNMT3a.,
    • after induction and end of treatment: minimal residual disease determined by WT1 and/or NPM1 transcripts levels.

    Measured: 5 years

Timeline

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

  1. First posted16 Jun 2015 (estimated)
  2. Study start18 Nov 2015
  3. Primary completion26 Feb 2021
  4. Study completion7 Sep 2023

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473146
Sponsor's protocol ID
2014-001395-65
Other IDs
2014
Acronym
ALFA1401
Status last verified
Feb 2024
First submitted
29 Apr 2015
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gemtuzumab ozogamicin (GO) in people with Acute Myeloid Leukemia, run by Versailles Hospital at 21 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 6 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death) (time frame: 5 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 NCT02473146.

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 Feb 2024.

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