Actively Recruiting
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2024-11-08
414
Participants Needed
48
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
CONDITIONS
Official Title
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
- WHO performance status 0-3
- Adequate renal (serum creatinine ≤ 2 x ULN) and liver function (total bilirubin ≤ 2 x ULN; ALT and AST ≤ 2.5 x ULN) unless due to leukemic involvement
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiogram
- Absence of severe neurological or psychiatric diseases, congestive heart failure, or active uncontrolled infection
- Absence of psychological, familial, sociological, or geographical conditions that may impair compliance
You will not qualify if you...
- 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
- Therapy-related AML
- Other active or progressive malignant diseases
- Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times ULN)
- Severe heart failure requiring diuretics
- Ejection fraction < 50%
- Uncontrolled infections
- Severe concomitant neurological or psychiatric diseases
- Pregnant patients or adults of reproductive potential not using effective birth control
- Women of childbearing potential must have a negative pregnancy test within 48 hours before chemotherapy
- Post-menopausal women must be amenorrheic for at least 12 months
- Male and female patients must agree to use effective barrier contraception during the study and for 6 months after stopping study drug
AI-Screening
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Trial Site Locations
Total: 48 locations
1
A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia
Alessandria, Italy
Actively Recruiting
2
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
Actively Recruiting
3
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
Actively Recruiting
4
AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto
Avellino, Italy
Actively Recruiting
5
AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto
Bari, Italy
Actively Recruiting
6
Policlinico S. Orsola - Malpighi - UOC Ematologia
Bologna, Italy
Actively Recruiting
7
Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia
Caserta, Italy
Actively Recruiting
8
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto, Italy
Actively Recruiting
9
Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia
Civitanova Marche, Italy
Actively Recruiting
10
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Italy
Actively Recruiting
11
Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia
Cremona, Italy
Actively Recruiting
12
Aou Careggi - Firenze - Sod Ematologia
Florence, Italy
Actively Recruiting
13
Asl Frosinone, Ospedale F. Spaziani - Ematologia
Frosinone, Italy
Actively Recruiting
14
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova, Italy
Actively Recruiting
15
Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia
Latina, Italy
Actively Recruiting
16
ASL Le/1 P.O. Vito Fazzi - UO Ematologia
Lecce, Italy
Actively Recruiting
17
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, Italy
Actively Recruiting
18
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Actively Recruiting
19
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, Italy
Actively Recruiting
20
ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo
Milan, Italy
Actively Recruiting
21
Aou Di Modena - Sc Ematologia
Modena, Italy
Actively Recruiting
22
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Naples, Italy
Actively Recruiting
23
Aou Federico Ii - Napoli - Uoc Ematologia
Naples, Italy
Actively Recruiting
24
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
Actively Recruiting
25
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani, Italy
Actively Recruiting
26
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, Italy
Actively Recruiting
27
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, Italy
Actively Recruiting
28
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Pavia, Italy
Actively Recruiting
29
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Actively Recruiting
30
Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti
Pesaro, Italy
Actively Recruiting
31
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, Italy
Actively Recruiting
32
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy
Actively Recruiting
33
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
Ravenna, Italy
Actively Recruiting
34
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Actively Recruiting
35
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, Italy
Actively Recruiting
36
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
Roma, Italy
Actively Recruiting
37
AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali
Roma, Italy
Actively Recruiting
38
Aou Sant'Andrea - Roma - Uoc Ematologia
Roma, Italy
Actively Recruiting
39
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Actively Recruiting
40
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
Roma, Italy
Actively Recruiting
41
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, Italy
Actively Recruiting
42
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Actively Recruiting
43
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, Italy
Actively Recruiting
44
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Actively Recruiting
45
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, Italy
Actively Recruiting
46
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
Treviso, Italy
Actively Recruiting
47
Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia
Trieste, Italy
Actively Recruiting
48
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, Italy
Actively Recruiting
Research Team
P
Paola Fazi
CONTACT
E
Enrico Crea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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