Ireland
--:--IST
Latest
Recruiting Phase 3

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

NCT04168502 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2020-09-24
Last updated
2024-11-08

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Gemtuzumab Ozogamicin →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed written informed consent according to ICH/EU/GCP and national/local laws 2. Patients aged between 18 and 60 years 3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy 4. 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) 5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML) 6. WHO performance status 0-3 7. 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 8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram 9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection 10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule. Exclusion Criteria: 1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy 2. Acute promyelocytic leukemia 3. Blast crisis of chronic myeloid leukemia 4. FLT3-ITD/TKD positive AML 5. AML supervening after other myeloproliferative disease 6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration 7. Therapy-related AML 8. Other active or progressive malignant diseases. 9. Inadequate renal or liver function (metabolic abnormalities \> 2-2.5 times the normal upper limit) 10. Severe heart failure requiring diuretics 11. Ejection fraction \< 50% 12. Uncontrolled infections 13. Severe concomitant neurological or psychiatric diseases 14. 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.

Primary outcome measure(s)

  • Activity of GO in combination with chemotherapy in terms of MRD negativity achievement — 2 months
    Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO

Trial sites (48)

FacilityCityRegionStatus
A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia Alessandria Italy Recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica Ancona Italy 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 Italy Recruiting
AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto Avellino Italy Recruiting
AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto Bari Italy Recruiting
Policlinico S. Orsola - Malpighi - UOC Ematologia Bologna Italy Recruiting
Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia Caserta Italy Recruiting
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo Castelfranco Veneto Italy Recruiting
Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia Civitanova Marche Italy Recruiting
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione Cona Italy Recruiting
Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia Cremona Italy Recruiting
Aou Careggi - Firenze - Sod Ematologia Florence Italy Recruiting
Asl Frosinone, Ospedale F. Spaziani - Ematologia Frosinone Italy Recruiting
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti Genova Italy Recruiting
Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia Latina Italy Recruiting
ASL Le/1 P.O. Vito Fazzi - UO Ematologia Lecce Italy Recruiting
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia Mestre Italy Recruiting
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Milan Italy Recruiting
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia Milan Italy Recruiting
ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo Milan Italy Recruiting
Aou Di Modena - Sc Ematologia Modena Italy Recruiting
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo Naples Italy Recruiting
Aou Federico Ii - Napoli - Uoc Ematologia Naples Italy Recruiting
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia Orbassano Italy Recruiting
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia Pagani Italy Recruiting
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Palermo Italy Recruiting
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia Palermo Italy Recruiting
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia Pavia Italy Recruiting
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo Perugia Italy Recruiting
Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti Pesaro Italy Recruiting
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Pescara Italy Recruiting
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti Piacenza Italy Recruiting
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia Ravenna Italy Recruiting
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia Reggio Emilia Italy Recruiting
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia Rimini Italy Recruiting
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia Roma Italy Recruiting
AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali Roma Italy Recruiting
Aou Sant'Andrea - Roma - Uoc Ematologia Roma Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica Roma Italy Recruiting
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia Roma Italy Recruiting

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04168502 on ClinicalTrials.gov ↗ ← All trials in Italy