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
NCT ID: NCT04589728
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
202 participants
OBSERVATIONAL
2021-02-23
2024-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Study group
All patients being observed during the study duration.
Venetoclax plus HMA
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.
Interventions
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Venetoclax plus HMA
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.
Eligibility Criteria
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Inclusion Criteria
* Deemed ineligible for intensive chemotherapy because of age (≥75 years), performance status or comorbidities as defined by the treating physicians, according to SIE/SIES/GITMO criteria;
* Eligible to receive the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021;
* Signed written informed consent according to ICH/EU/GCP and national local laws.
Exclusion Criteria
* Previous first-line treatments for AML;
* Previous treatments with HMA.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Locations
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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
Florence, , 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
Milan, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, , Italy
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
Milan, , 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
Countries
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Other Identifiers
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AML2320
Identifier Type: -
Identifier Source: org_study_id
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