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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04230564
Enrollment
0
Registered
2020-01-18
Start date
2020-10-31
Completion date
2021-03-31
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia (AML)

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

Interventions

DRUGazacitidine

Patients taking azacitidine

DRUGvenetoclax

patients taking venetoclax

patients taking glasdegib

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026