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

July 7, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in patients with AML unfit for intensive chemotherapy in a "real-life" scenario. At least 104 AML adult patients ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021 will be enrolled. 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.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
      • Bologna, Italy
        • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
      • Brescia, Italy
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
      • Firenze, Italy
        • Aou Careggi - Firenze - Sod Ematologia
      • Foggia, Italy
        • Aou Ospedali Riuniti - Foggia - Uoc Ematologia
      • Lecce, Italy
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
      • Mestre, Italy
        • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
      • Milano, 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
      • Orbassano, Italy
        • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
      • Pagani, Italy
        • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
      • Palermo, Italy
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
      • Perugia, Italy
        • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
      • Pescara, Italy
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
      • Potenza, Italy
        • Ao Regionale S. Carlo - Potenza - Sic Ematologia
      • Roma, Italy
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
      • Salerno, Italy
        • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
      • Sassari, Italy
        • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
      • Sassuolo, Italy
        • Ospedale Di Sassuolo Spa - Ematologia
      • Siena, Italy
        • Aou Senese - Uoc Ematologia E Trapianti
      • Torino, Italy
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
      • Viterbo, Italy
        • Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
All patients being observed during the study duration.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 15 months
Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

September 8, 2024

Study Completion (Actual)

September 8, 2024

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML2320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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