Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Gemtuzumab

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Gemtuzumab Ozogamicin (Mylotarg) administered in any form or combination

Gemtuzumab Ozogamicin

Pfizer CT.gov Call Center

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.

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

Characteristics, Treatment Patterns, and Clinical Outcomes in Acute Myeloid Leukemia (AML) Patients Using Mylotarg - a US Real-World Study Using Electronic Medical Record Data

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Duration of therapy was time from the initiation of Mylotarg to the last date of Mylotarg therapy, regardless of line of therapy (duration could continue into subsequent lines of therapy), study end date, or death, whichever came first.

rwEFS defined as time from treatment initiation date (for first line of Mylotarg-containing therapy) to date of treatment failure (TF), relapse from complete response (CR) or better, death from any cause, whichever came first. TF defined as failure to achieve CR or better following up to 3 cycles of Mylotarg. Time origin for rwEFS was start of Mylotarg in first line of therapy in which it was used. Terminal event for analysis of rwEFS was earlier of treatment failure, relapse from CR or better, death. CR is defined as having less than (\<) 5% blasts in the bone marrow and 0% blasts in the peripheral blood. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

rwRFS was defined as the time 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. The time origin for rwRFS was the start of Mylotarg in the first line of therapy in which it was used. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

rwOS was defined as the time from the start of the first Mylotarg use till the date of death. Participants who were not indicated to be deceased in clinical records or Social Security Disability Insurance (SSDI) records were censored for rwOS analysis as of the later of 1) the latest date known alive within the clinical record, 2) 4 months prior to the date of most recent SSDI update. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

First positive response was assessed by physician as first response from any of the following: CR, partial response (PR), stable disease (SD) and progressive disease (PD). CR is defined as having \< 5% blasts in the bone marrow and 0% blasts in the peripheral blood. PR is defined as having 5 to 25% bone marrow blasts with \> 50% reduction in blasts and peripheral blood count recovery. SD is defined as having no change in bone marrow blasts. PD is defined as having relapse following response. Participant for whom record did not indicate one of these classification classed as not evaluable (NE).

Pfizer

This study involved data that existed as structured data by the time of study start. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) was not met, hence, safety data was not planned to be collected and reported.

Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin \[mean number of doses of gemtuzumab administered = 1 per participant\]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.

Mylotarg

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Body Mass Index (BMI)

Here, number of participants with their insurance status as 'private only, public only, both (public and private insurance), neither (unknown or undocumented)' were reported. Private only insurance was purchased by the participants. Public only insurance was provided by the federal or state funds.

Insurance Status

Here 'number analyzed" signifies participants evaluable for this baseline measure.

Height of Participants

Body Weight

Here, number of participants were classified in 5 categories (Midwest, northeast, south, west and undocumented \[unknown\] region) according to their region of residence.

Region of Residence

Here, number of participants were classified in 4 categories (congestive heart failure, connective tissue disease, diabetes and myocardial infarction) according to different type of comorbid condition.

Here "number analyzed" signifies participants evaluable for this baseline measure.

Number of Participants With Comorbidities

Charlson Comorbidity Index scored the cumulative severity of a participant's comorbidities. Total score ranged from 0 to 9. A score of zero indicated that no comorbidities were found. The higher the score, the more likely the cumulative severity of a participant's comorbidities.

Mean Charlson Comorbidity Index of Participants

ECOG PS was used to assess physical health of participant, ranged from 0 (most active) to 5 (dead) where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2=ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>)50 percent (%) of waking hours; 3=capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5=dead.

Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Here, number of participants were classified according to their AML type. Index date was defined as the date of initial AML diagnosis.

AML Stage at Index Date

t(6;9)(p23:q34.1) Testing

t(v;11q23.3) Testing

t(9;22)(q34.1;q11.2) Testing

inv(3)(q21.3q26.2)³ or t(3;3)(q21.3;q26.2) Testing

-5 or del(5q); -7; -17/abn(17p) Testing

Complex karyotype Testing

Monosomal karyotype Testing

t(8;21)(q22;q22.1) Testing

inv(16)(p13.1q22)¹ or t(16;16)(p13.1;q22) Testing

Here, number of participants were classified according to positive results (if they had test result data available and denoted as "yes") and and negative results (if they did not had test result data and denoted as "no") in cytogenetic/ Fluorescence in situ Hybridization (FISH) testing. Cytogenetic/FISH testing included: t(6;9)(p23:q34.1), t(v;11q23.3), t(9;22)(q34.1;q11.2), inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2), -5 or del(5q); -7; -17/abn(17p), complex karyotype, monosomal karyotype, t(8;21)(q22;q22.1), inv(16)(p13.1q22) and t(16;16)(p13.1;q22) tests.

Number of Participants With Results for Cytogenetic/FISH Testing at Initial AML Diagnosis

Analysis population included all eligible participants who were included in this study.

Pfizer ClinicalTrials.gov Call Center

Analysis population included all participants included in this study.

Real-World Event-Free Survival (rwEFS)

Real-World Relapse Free Survival (rwRFS)

Real-World Overall Survival (rwOS)

First line (1L) Therapy

Second line (2L) Therapy

Third line (3L) Therapy

Analysis population included all participants included in this study. Here, 'number analyzed' signifies participants evaluable for each specified category.

Number of Participants With First Positive Response

Mylotarg in 1L therapy

Mylotarg in 2L therapy

Mylotarg in 3L therapy

Duration of Therapy

rwEFS defined as time from treatment initiation date (for first line of Mylotarg-containing therapy) to date of TF, relapse from CR or better, death from any cause, whichever came first. TF defined as failure to achieve CR or better following up to 3 cycles of Mylotarg. Time origin for rwEFS was start of Mylotarg in first line of therapy in which it was used. Terminal event for analysis of rwEFS was earlier of treatment failure, relapse from CR or better, death. CR is defined as having \< 5% blasts in the bone marrow and 0% blasts in the peripheral blood. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

Analysis population included all participants included in this study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Spots Global Cancer Trial Database for A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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