N/A
Completed N=32
A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World
Leukemia, Myeloid, Acute
Source: ClinicalTrials.gov NCT04337138 ↗
Enrolled (actual)
32
Serious AEs
—
Results posted
Aug 2021
Primary outcomePrimary: Real-World Event-Free Survival (rwEFS) — 1.66 months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real-World Event-Free Survival (rwEFS) |
1.66 | — |
| PRIMARY Real-World Relapse Free Survival (rwRFS) |
4.87 | — |
| PRIMARY Real-World Overall Survival (rwOS) |
6.15 | — |
| PRIMARY Number of Participants With First Positive Response |
9; 7; 0; 2; 5; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04337138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.