Acute Myeloid Leukemia Real World Treatment Patterns

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

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

Study Overview

• Status: Withdrawn
• Conditions: Leukemia, Myeloid, Acute
• Intervention / Treatment: Drug: azacitidine; Drug: venetoclax; Drug: glasdegib

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. 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.

2. 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:

   1. AZA
   2. GLAS
   3. VEN
3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AML; Patients diagnosed with AML	Drug: azacitidine; Patients taking azacitidine; Drug: venetoclax; patients taking venetoclax; Drug: glasdegib; patients taking glasdegib

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2020
• Primary Completion (Estimated): March 31, 2021
• Study Completion (Estimated): March 31, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia (AML)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Venetoclax; Azacitidine
• Other Study ID Numbers: B1371038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.