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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04589728

Enrollment

202

Registered

2020-10-19

Start date

2021-02-23

Completion date

2024-09-08

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

venetoclax, unfit AML patients, Hypomethylating agents

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.

Interventions

DRUGVenetoclax plus HMA

patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026