Acute Myeloid Leukemia Clinical Trial

Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review

Summary

The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.

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Full Description

The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.

For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.

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Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
Known FLT3 mutation status
Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
The medical records related to AML for the patient are available to the physician and can be abstracted for this study
The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
Initiation date of first treatment after AML diagnosis OR date of being classified as relapsed from or being refractory to initial treatment (R/R) is between January 1, 2013 and December 31, 2015

Exclusion Criteria:

Not applicable

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

1027

Study ID:

NCT03047083

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Global Development, Inc.

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There is 1 Location for this study

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Sermo
Charlotte North Carolina, 28209, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

1027

Study ID:

NCT03047083

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Global Development, Inc.

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