Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Myeloid Leukemia Real World Treatment Patterns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230564
Recruitment Status : Withdrawn (Study was cancelled prior to any enrollment)
First Posted : January 18, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Leukemia, Myeloid, Acute Drug: azacitidine Drug: venetoclax Drug: glasdegib

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
AML
Patients diagnosed with AML
 Drug: azacitidine
Patients taking azacitidine

Drug: venetoclax
patients taking venetoclax

Drug: glasdegib
patients taking glasdegib


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Overall survival was the duration from diagnosis of disease to death.

  2. Event Free Survival [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first

  3. Relapse Free Survival [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first

  4. Best response [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Best response recorded from treatment start until disease progression/recurrence

  5. Time to best response [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Time from treatment initiation until best response recorded

  6. Duration of best response [ Time Frame: January 1, 2012 to January 10, 2020 ]
    Time from best response achieved until lose of response or the end of the record, whichever occurs first


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230564


Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04230564    
Other Study ID Numbers: B1371038
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (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/data_requests.
Keywords provided by Pfizer:
Acute Myeloid Leukemia (AML)
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
 Venetoclax
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors