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
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Pfizer
- Primary Endpoint
- Overall Survival
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
Arms & Interventions
AML
Patients diagnosed with AML
Intervention: azacitidine (Drug)
AML
Patients diagnosed with AML
Intervention: venetoclax (Drug)
AML
Patients diagnosed with AML
Intervention: glasdegib (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: January 1, 2012 to January 10, 2020
Overall survival was the duration from diagnosis of disease to death.
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
Time to best response
Time Frame: January 1, 2012 to January 10, 2020
Time from treatment initiation until best response recorded
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
Best response
Time Frame: January 1, 2012 to January 10, 2020
Best response recorded from treatment start until disease progression/recurrence
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
Secondary Outcomes
No secondary outcomes reported