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

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Venetoclax plus HMA

• Registration Number: NCT04589728
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

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 Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2021-02-23
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Venetoclax plus HMA	All patients being observed during the study duration.

Primary Outcome Measures

Name	Time	Method
Overall Survival	15 months	Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax

Trial Locations

Locations (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; 🇮🇹 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

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