Clinical trial NCT04337138: A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World
Official title: Characteristics, Treatment Patterns, and Clinical Outcomes in Acute Myeloid Leukemia (AML) Patients Using Mylotarg - a US Real-World Study Using Electronic Medical Record Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid, Acute
Keywords: AML
Mylotarg
gemtuzumab
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include adult patients diagnosed with AML who, at any point on or after September 1, 2017 received Mylotarg, alone or in combination with other agents for newly diagnosed or relapsed refractory AML.

Brief summary: The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States oncology electronic medical record (EMR) data. All study data are secondary data and will have been collected retrospectively from existing clinical data originally collected as part of routine care.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of acute myeloid leukemia (AML) on or after 01 December 2014 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record;
* Receipt of Mylotarg at any point during first three lines of therapy following initial AML diagnosis;
* Age greater than or equal to 18 years at initial diagnosis of AML.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Real-World Event-Free Survival (rwEFS)
timeFrame: From treatment initiation date to date of TF, relapse from CR or better, death from any cause, whichever came first (maximum duration of 3 years)
measure: Real-World Relapse Free Survival (rwRFS)
timeFrame: From the treatment initiation date (during the first line of Mylotarg-containing therapy) to the date of a relapse event, or death from any cause, whichever came first (maximum duration of 3 years)
measure: Real-World Overall Survival (rwOS)
timeFrame: From the start of the first Mylotarg use till death (maximum duration of 3 years)
measure: Number of Participants With First Positive Response
timeFrame: From the first qualifying Mylotarg-containing line of therapy to the end of the third line of therapy or the end of record, whichever occurs first (maximum duration of 3 years)
Secondary outcomes:
Other outcomes:
measure: Duration of Therapy
timeFrame: From the initiation of Mylotarg to the last date of Mylotarg therapy (maximum duration of 3 years)
Locations:
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: