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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

Venetoclax plus HMA

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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