Acute Myeloid Leukemia Clinical Trial
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
NCT number | NCT04589728 |
Other study ID # | AML2320 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 23, 2021 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged = 18 years with a diagnosis of previously untreated primary or secondary AML; - 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: - Acute promyelocytic Leukemia; - Previous first-line treatments for AML; - Previous treatments with HMA. |
Country | Name | City | State |
---|---|---|---|
Italy | 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 |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Malattie EMatologiche dell'Adulto |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax | 15 months |
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---|---|---|---|
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