RecruitingPhase 3NCT04168502

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

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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrollment

414 participants

Start Date

Sep 24, 2020

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called gemtuzumab ozogamicin to standard chemotherapy improves outcomes for adults newly diagnosed with a certain type of acute myeloid leukemia (AML) — a cancer of the blood. Researchers are measuring minimal residual disease (MRD), which is how much cancer remains after initial treatment. **You may be eligible if...** - You are between 18 and 60 years old - You have been newly diagnosed with AML (not the promyelocytic type) and have not yet received chemotherapy - Your AML is classified as favorable or intermediate risk **You may NOT be eligible if...** - You have previously received chemotherapy (except brief hydroxyurea) - You have acute promyelocytic leukemia (APL) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemtuzumab Ozogamicin

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

Locations(48)

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

Alessandria, Italy

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

Ancona, Italy

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

Ascoli Piceno, Italy

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

Avellino, Italy

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

Bari, Italy

Policlinico S. Orsola - Malpighi - UOC Ematologia

Bologna, Italy

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

Caserta, Italy

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

Castelfranco Veneto, Italy

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

Civitanova Marche, Italy

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

Cona, Italy

Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia

Cremona, Italy

Aou Careggi - Firenze - Sod Ematologia

Florence, Italy

Asl Frosinone, Ospedale F. Spaziani - Ematologia

Frosinone, Italy

Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti

Genova, Italy

Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia

Latina, Italy

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

Lecce, Italy

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

Mestre, Italy

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, Italy

Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

Milan, Italy

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

Milan, Italy

Aou Di Modena - Sc Ematologia

Modena, Italy

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

Naples, Italy

Aou Federico Ii - Napoli - Uoc Ematologia

Naples, Italy

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

Orbassano, Italy

Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

Pagani, Italy

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

Palermo, Italy

Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

Palermo, Italy

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

Pavia, Italy

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

Perugia, Italy

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

Pesaro, Italy

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

Pescara, Italy

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

Piacenza, Italy

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

Ravenna, Italy

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

Reggio Emilia, Italy

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

Rimini, Italy

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

Roma, Italy

AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali

Roma, Italy

Aou Sant'Andrea - Roma - Uoc Ematologia

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, Italy

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

Roma, Italy

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

Roma, Italy

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

Roma, Italy

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

San Giovanni Rotondo, Italy

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

Sassari, Italy

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

Torino, Italy

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

Treviso, Italy

Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia

Trieste, Italy

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

Udine, Italy

View Full Details on ClinicalTrials.gov

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NCT04168502

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