Acute Myeloid Leukemia Real World Treatment Patterns

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 28, 2021

Interventions

  • Drug: azacitidine
    • Patients taking azacitidine
  • Drug: venetoclax
    • patients taking venetoclax
  • Drug: glasdegib
    • patients taking glasdegib

Arms, Groups and Cohorts

  • AML
    • Patients diagnosed with AML

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival
    • Time Frame: January 1, 2012 to January 10, 2020
    • Overall survival was the duration from diagnosis of disease to death.
  • Event Free Survival
    • Time Frame: January 1, 2012 to January 10, 2020
    • 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
  • Relapse Free Survival
    • Time Frame: January 1, 2012 to January 10, 2020
    • Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first
  • Best response
    • Time Frame: January 1, 2012 to January 10, 2020
    • Best response recorded from treatment start until disease progression/recurrence
  • Time to best response
    • Time Frame: January 1, 2012 to January 10, 2020
    • Time from treatment initiation until best response recorded
  • Duration of best response
    • Time Frame: January 1, 2012 to January 10, 2020
    • Time from best response achieved until lose of response or the end of the record, whichever occurs first

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer
  • Overall Contact(s)
    • Pfizer CT.gov Call Center, 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

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