AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3NCT04168502

Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

A Phase 3 study testing Gemtuzumab Ozogamicin in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 48 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Gemtuzumab Ozogamicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
48 sitesItaly
Study dates
24 Sep 2020to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed written informed consent according to ICH/EU/GCP and national/local laws
  • Patients aged between 18 and 60 years
  • Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
  • Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration)
  • Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
  • WHO performance status 0-3
Show all 10Show fewer
  • Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram
  • Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
  • Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.

Who cannot join

  • Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
  • Acute promyelocytic leukemia
  • Blast crisis of chronic myeloid leukemia
  • FLT3-ITD/TKD positive AML
  • AML supervening after other myeloproliferative disease
  • AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration
Show all 14Show fewer
  • Therapy-related AML
  • Other active or progressive malignant diseases.
  • Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times the normal upper limit)
  • Severe heart failure requiring diuretics
  • Ejection fraction < 50%
  • Uncontrolled infections
  • Severe concomitant neurological or psychiatric diseases
  • Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.

Trial locations and contacts

48 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paola Fazi contact

0670390528

p.fazi@gimema.it

Enrico Crea contact

0670390514

e.crea@gimema.it

48 sites in 1 country

Italy48 sites, 48 recruiting

  • A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia

    Alessandria

    Zallio

    Recruiting

  • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica

    Ancona

    Attilio Olivieri, a.olivieri@univpm.it

    Recruiting

  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia

    Ascoli Piceno

    Piero Galieni, 3388149974, piero.galieni@sanita.marche.it

    Recruiting

  • AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto

    Avellino

    Storti

    Recruiting

  • AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto

    Bari

    Carluccio

    Recruiting

  • Policlinico S. Orsola - Malpighi - UOC Ematologia

    Bologna

    Curti

    Recruiting

  • Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia

    Caserta

    Andrea Camera, 330344420, ancamera@unina.it

    Recruiting

  • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo

    Castelfranco Veneto

    Michele Gottardi, 3476260749, michele.gottardi@aulss2.veneto.it

    Recruiting

  • Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia

    Civitanova Marche

    Milena Mirabile, milena.mirabile@hotmail.it

    Recruiting

  • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione

    Cona

    Maria Ciccone, m.ciccone@ospfe.it

    Recruiting

  • Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia

    Cremona

    Alfredo Molteni, 338/3169286, alfredo.molteni@asst-cremona.it

    Recruiting

  • Aou Careggi - Firenze - Sod Ematologia

    Florence

    Barbara Scappini, scappinib@aou-careggi.toscana.it

    Recruiting

  • Asl Frosinone, Ospedale F. Spaziani - Ematologia

    Frosinone

    Vincenza Martini, vincenzamartini@inwind.it

    Recruiting

  • Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti

    Genova

    Germana Beltrami, germana.beltrami@hsanmartino.it

    Recruiting

  • Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia

    Latina

    Cimino

    Recruiting

  • ASL Le/1 P.O. Vito Fazzi - UO Ematologia

    Lecce

    Di Renzo

    Recruiting

  • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia

    Mestre

    Renato Bassan, Renato.Bassan@aulss3.veneto.it

    Recruiting

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milan

    Roberto Cairoli, roberto.cairoli@ospedaleniguarda.it

    Recruiting

  • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

    Milan

    Fabio Ciceri, ciceri.clinicaltrials@hsr.it

    Recruiting

  • ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo

    Milan

    Elisabetta Todisco, Elisabetta.Todisco@ieo.it

    Recruiting

  • Aou Di Modena - Sc Ematologia

    Modena

    Mario Luppi, mario.luppi@unimore.it

    Recruiting

  • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo

    Naples

    Felicetto Ferrara, 3388272964, felicettoferrara@katamail.com

    Recruiting

  • Aou Federico Ii - Napoli - Uoc Ematologia

    Naples

    Fabrizio Pane, fabrizio.pane@unina.it

    Recruiting

  • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia

    Orbassano

    Daniela Cilloni, daniela.cilloni@unito.it

    Recruiting

  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

    Pagani

    Catello Califano, c.califano@aslsalerno.it

    Recruiting

  • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

    Palermo

    Antonino Mulè, a.mule@villasofia.it

    Recruiting

  • Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

    Palermo

    Maria Enza Mitra, memitra@yahoo.com

    Recruiting

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia

    Patrizia Zappasodi, p.zappasodi@smatteo.pv.it

    Recruiting

  • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo

    Perugia

    Maria Paola Martelli, mpmartelli@libero.it

    Recruiting

  • Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti

    Pesaro

    Giuseppe Visani, giuseppe.visani@ospedalimarchenord.it

    Recruiting

  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica

    Pescara

    Prassede Salutari, prassede.salutari@gmail.com

    Recruiting

  • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

    Piacenza

    Daniele Vallisa, d.vallisa@ausl.pc.it

    Recruiting

  • Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia

    Ravenna

    Michela Rondoni, michela.rondoni@auslromagna.it

    Recruiting

  • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

    Reggio Emilia

    Alessia Tieghi, alessia.tieghi@ausl.re.it

    Recruiting

  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

    Rimini

    Anna Maria Mianulli, annamariamianulli@libero.it

    Recruiting

  • Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia

    Roma

    Laura Cudillo, lcudillo@hsangiovanni.roma.it

    Recruiting

  • AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali

    Roma

    Adriano Venditti, adriano.venditti@uniroma2.it

    Recruiting

  • Aou Sant'Andrea - Roma - Uoc Ematologia

    Roma

    Agostino Tafuri, agostino.tafuri@ospedalesantandrea.it

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma

    Patrizia Chiusolo, patrizia.chiusolo@Unicatt.it

    Recruiting

  • Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia

    Roma

    Andrea Mengarelli, andreamengarelli@libero.it

    Recruiting

  • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali

    Roma

    Giuseppe Avvisati, g.avvisati@unicampus.it

    Recruiting

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma

    Maurizio Martelli, martelli@bce.uniroma1.it

    Recruiting

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

    San Giovanni Rotondo

    Nicola Cascavilla, n.cascavilla@operapadrepio.it

    Recruiting

  • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia

    Sassari

    Claudio Fozza, cfozza@uniss.it

    Recruiting

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

    Torino

    Ernesta Audisio, eaudisio@cittadellasalute.to.it

    Recruiting

  • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana

    Treviso

    Endri Mauro, endri.mauro@aas5.sanita.fvg.it

    Recruiting

  • Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia

    Trieste

    Francesco Zaja, francesco.zaja@asuits.sanita.fvg.it

    Recruiting

  • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica

    Udine

    Anna Candoni, candoni.anna@aoud.sanita.fvg.it

    Recruiting

Other trials in Italy

About this study

Official title: Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML

MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.

Read the detailed description

Setting up a multicenter, MRD (Minimal Residual Disease)-driven study that relies on addition of gemtuzumab ozogamicin to conventional chemotherapy to reduce the pre-transplant levels of MRD of patients with favorable/intermediate-risk (according to ELN 2017) AML. Post-consolidation assessment of MRD will be exploited to establish the final risk assignment and to verify whether the delivery of a post remission therapy intensity (AuSCT, Autologous Stem Cell Transplant, vs ASCT, Allogeneic Stem Cell Transplant) of which is MRD-driven will improve the outcome in terms of anti-leukemic efficacy.

Being tested
Gemtuzumab Ozogamicin
Keywords
De-novo, Favorable risk, Intermediate risk, Gemtuzumab ozogamicin, Acute Myeloid Leukemia
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 OzogamicinDrug

    Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine

Study groups in NCT04168502
Study groupRoleWhat they receive
Experimental armExperimentalInduction: Gemtuzumab 3 mg/m2 day 1,4,7 Daunorubicin 60 mg/m2 day 1-3 Cytosine arabinoside 200 mg/m2 day 1-7 Consolidation: Gemtuzumab 3 mg/m2 day 1 Daunorubicin 50 mg/m2 day 4-6 Cytosine arabinoside 500 mg/m2 twice a day, day 1-6 Allogeneic transplantation or Autologous transplantation according to MRD level clinical observation
Receives: Drug: Gemtuzumab Ozogamicin

What is being measured

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

  1. Activity of GO in combination with chemotherapy in terms of MRD negativity achievement

    Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO

    Measured: 2 months

Timeline

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

  1. First posted19 Nov 2019
  2. Study start24 Sep 2020
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2027 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
414 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168502
Sponsor's protocol ID
AML1819
Status last verified
Oct 2024
First submitted
11 Nov 2019
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemtuzumab Ozogamicin in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 48 sites in Italy.

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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Italy. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activity of GO in combination with chemotherapy in terms of MRD negativity achievement (time frame: 2 months). 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 NCT04168502.

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 8 Nov 2024.

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