A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World

Pfizer

Status: Completed

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Gemtuzumab Ozogamicin

Study type: Observational

Funder types: Industry

Identifiers

NCT04337138

B1761033

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design