Acute Myeloid Leukemia Real World Treatment Patterns

NCT04230564

Last updated date
Study Location
Concerto HealthAI
Memphis, Tennessee, 38119, United States
Contact
1-800-718-1021
ClinicalTrials[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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:

  • Describe patient demographic and clinical characteristics
  • Describe treatment patterns
  • Describe effectiveness outcomes
  • Evaluate tumor response
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
  • Drug: azacitidine
    Patients taking azacitidine
  • Drug: venetoclax
    patients taking venetoclax
  • Drug: glasdegib
    patients taking glasdegib
Study Groups/Cohorts AML
Patients diagnosed with AML
Interventions:
  • Drug: azacitidine
  • Drug: venetoclax
  • Drug: glasdegib
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 Not yet recruiting
Estimated Enrollment
 (submitted: January 13, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2021
Estimated Primary Completion Date February 28, 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:

  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.

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
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries United States
Removed Location Countries  
 
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
Plan to Share IPD:No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2020