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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Venetoclax plus HMA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>All patients being observed during the study duration. | Drug: Venetoclax plus HMA<br>* patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venetoclax, unfit AML patients, Hypomethylating agents