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
- Diseases
- Acute myeloid leukemia
- 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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Asst Degli Spedali Civili Di Brescia - Uo Ematologia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Aou Careggi - Firenze - Sod Ematologia Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Aou Ospedali Riuniti - Foggia - Uoc Ematologia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia Coordinator of this site? Confirm its status | Mestre | Italy | Unknown status |
| Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia Coordinator of this site? Confirm its status | Pagani | Italy | Unknown status |
| Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Ao Regionale S. Carlo - Potenza - Sic Ematologia Coordinator of this site? Confirm its status | Potenza | Italy | Unknown status |
| Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
| Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
| Ospedale Di Sassuolo Spa - Ematologia Coordinator of this site? Confirm its status | Sassuolo | Italy | Unknown status |
| Aou Senese - Uoc Ematologia E Trapianti Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia Coordinator of this site? Confirm its status | Viterbo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.