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NCT04589728Completed

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

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

Source: ClinicalTrials.gov · Last updated 8 Jul 2025

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Observational
Enrollment
202 (actual)
First submitted
9 Oct 2020
Start date
23 Feb 2021
Primary completion date
8 Sept 2024
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT number
NCT04589728

What you commit to

  • Study type: Observational
  • Participants enrolled: 202
  • From 23 Feb 2021 to the primary completion date, 8 Sept 2024
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous first-line treatments for AML;
  • Previous treatments with HMA.

Other

  • Acute promyelocytic Leukemia;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
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BergamoItalyUnknown status
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
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BolognaItalyUnknown status
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
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BresciaItalyUnknown status
Aou Careggi - Firenze - Sod Ematologia
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FlorenceItalyUnknown status
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
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FoggiaItalyUnknown status
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
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LecceItalyUnknown status
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
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MestreItalyUnknown status
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
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MilanItalyUnknown status
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
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MilanItalyUnknown status
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
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MilanItalyUnknown status
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
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OrbassanoItalyUnknown status
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
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PaganiItalyUnknown status
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
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PalermoItalyUnknown status
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
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PerugiaItalyUnknown status
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
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PescaraItalyUnknown status
Ao Regionale S. Carlo - Potenza - Sic Ematologia
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PotenzaItalyUnknown status
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
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RomaItalyUnknown status
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
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SalernoItalyUnknown status
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
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SassariItalyUnknown status
Ospedale Di Sassuolo Spa - Ematologia
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SassuoloItalyUnknown status
Aou Senese - Uoc Ematologia E Trapianti
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SienaItalyUnknown status
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
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TorinoItalyUnknown status
Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia
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ViterboItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.