ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
2. Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:
1. AZA
2. GLAS
3. VEN
3. Age ≥18 years at initial diagnosis of AML.
Patients meeting any of the following criteria will not be included in the study:
1. 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.
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Descriptive Information | |||||
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Brief Title | Acute Myeloid Leukemia Real World Treatment Patterns | ||||
Official Title | Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data | ||||
Brief Summary | Among patients with a diagnosis of AML who received non-intensive chemotherapy:
| ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy | ||||
Condition | Leukemia, Myeloid, Acute | ||||
Intervention |
| ||||
Study Groups/Cohorts | AML
Patients diagnosed with AML Interventions:
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment | 0 | ||||
Original Estimated Enrollment | 200 | ||||
Estimated Study Completion Date | March 31, 2021 | ||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: 1. 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. | ||||
Sex/Gender |
| ||||
Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | United States | ||||
Administrative Information | |||||
NCT Number | NCT04230564 | ||||
Other Study ID Numbers | B1371038 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | February 2021 |