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
1 other identifier
observational
202
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2024
CompletedJuly 8, 2025
July 1, 2025
3.5 years
October 9, 2020
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax
15 months
Study Arms (1)
Study group
All patients being observed during the study duration.
Interventions
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.
Eligibility Criteria
patients with a diagnosis of AML ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021.
You may qualify if:
- 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.
You may not qualify if:
- Acute promyelocytic Leukemia;
- Previous first-line treatments for AML;
- Previous treatments with HMA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 19, 2020
Study Start
February 23, 2021
Primary Completion
September 8, 2024
Study Completion
September 8, 2024
Last Updated
July 8, 2025
Record last verified: 2025-07