Acute Myeloid Leukemia Real World Treatment Patterns

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04230564

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute	Drug: azacitidine Drug: venetoclax Drug: glasdegib

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Oct 31, 2020

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
AML Patients diagnosed with AML	Drug: azacitidine Patients taking azacitidine Drug: venetoclax patients taking venetoclax Drug: glasdegib patients taking glasdegib

Arm

Intervention/Treatment

AML

Patients diagnosed with AML

Drug: azacitidine

Patients taking azacitidine

Drug: venetoclax

patients taking venetoclax

Drug: glasdegib

patients taking glasdegib

Outcome Measures

Primary Outcome Measures

Overall Survival [January 1, 2012 to January 10, 2020]
Overall survival was the duration from diagnosis of disease to death.
Event Free Survival [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 [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 [January 1, 2012 to January 10, 2020]
Best response recorded from treatment start until disease progression/recurrence
Time to best response [January 1, 2012 to January 10, 2020]
Time from treatment initiation until best response recorded
Duration of best response [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.