- ICH GCP
- US Clinical Trials Registry
- 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
July 16, 2021 updated by: Pfizer
Characteristics, Treatment Patterns, and Clinical Outcomes in Acute Myeloid Leukemia (AML) Patients Using Mylotarg - a US Real-World Study Using Electronic Medical Record Data
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10017
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Real-World Event-Free Survival (rwEFS)
Time Frame: 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)
|
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.
|
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)
|
Real-World Relapse Free Survival (rwRFS)
Time Frame: 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)
|
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.
|
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)
|
Real-World Overall Survival (rwOS)
Time Frame: From the start of the first Mylotarg use till death (maximum duration of 3 years)
|
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.
|
From the start of the first Mylotarg use till death (maximum duration of 3 years)
|
Number of Participants With First Positive Response
Time Frame: 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)
|
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).
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Therapy
Time Frame: From the initiation of Mylotarg to the last date of Mylotarg therapy (maximum duration of 3 years)
|
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.
|
From the initiation of Mylotarg to the last date of Mylotarg therapy (maximum duration of 3 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2020
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 7, 2020
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1761033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia, Myeloid, Acute
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
Kronos BioActive, not recruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States, Spain
Clinical Trials on Gemtuzumab Ozogamicin
-
University Hospital HeidelbergTerminated
-
University Hospital Carl Gustav CarusUnknownAcute Myeloid Leukemia | Allogeneic TransplantationGermany
-
PfizerCompleted
-
University of AarhusCompleted
-
PfizerCompletedLeukemiaUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)UnknownMyelodysplastic SyndromesUnited States
-
European Organisation for Research and Treatment...Gruppo Italiano Malattie EMatologiche dell'AdultoUnknownLeukemiaBelgium, Italy, Netherlands
-
Medical College of WisconsinCompletedRelapsed Adult AMLUnited States
-
Versailles HospitalUnknown
-
PfizerCompletedPharmacokinetics | Safety | ECGCanada, Spain, United States, Hungary, Poland, United Kingdom