Acute Myeloid Leukemia Real World Treatment Patterns

Study Overview
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Brief Summary
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Among patients with a diagnosis of AML who received non-intensive chemotherapy: Describe patient demographic and clinical characteristics Describe treatment patterns Describe effectiveness outcomes Evaluate tumor response

Official Title
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Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data

Conditions
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Leukemia, Myeloid, Acute

Intervention / Treatment
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* Drug: azacitidine
* Drug: venetoclax
* Drug: glasdegib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record. Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent: AZA GLAS VEN Age ≥18 years at initial diagnosis of AML. Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: 1. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

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 |
| --- | --- |
| AML<br>Patients diagnosed with AML | Drug: azacitidine<br>* Patients taking azacitidine<br>Drug: venetoclax<br>* patients taking venetoclax<br>Drug: glasdegib<br>* patients taking glasdegib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival was the duration from diagnosis of disease to death. | January 1, 2012 to January 10, 2020 | 
| Event Free Survival | Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first | January 1, 2012 to January 10, 2020 | 
| Relapse Free Survival | Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first | January 1, 2012 to January 10, 2020 | 
| Best response | Best response recorded from treatment start until disease progression/recurrence | January 1, 2012 to January 10, 2020 | 
| Time to best response | Time from treatment initiation until best response recorded | January 1, 2012 to January 10, 2020 | 
| Duration of best response | Time from best response achieved until lose of response or the end of the record, whichever occurs first | January 1, 2012 to January 10, 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia (AML)