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Brief Title: Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
Official Title: Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit Patients With Acute Myeloid Leukemia Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
Study ID: NCT04589728
Brief Summary: This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.
Detailed Description: This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in patients with AML unfit for intensive chemotherapy in a "real-life" scenario. At least 104 AML adult patients ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021 will be enrolled. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia, Bergamo, , Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia, Bologna, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia, Brescia, , Italy
Aou Careggi - Firenze - Sod Ematologia, Firenze, , Italy
Aou Ospedali Riuniti - Foggia - Uoc Ematologia, Foggia, , Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia, Lecce, , Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia, Mestre, , Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia, Milano, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora, Milano, , Italy
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia, Milano, , 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
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo, Perugia, , Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica, Pescara, , Italy
Ao Regionale S. Carlo - Potenza - Sic Ematologia, Potenza, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali, Roma, , Italy
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche, Salerno, , Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia, Sassari, , Italy
Ospedale Di Sassuolo Spa - Ematologia, Sassuolo, , Italy
Aou Senese - Uoc Ematologia E Trapianti, Siena, , Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2, Torino, , Italy
Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia, Viterbo, , Italy