Acute Myeloid Leukemia Real World Treatment Patterns

NCT04230564 | Withdrawn

• 1 other identifier: B1371038
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (6)

• Overall Survival

  Overall survival was the duration from diagnosis of disease to death.

  January 1, 2012 to January 10, 2020

• Event Free Survival

  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

  January 1, 2012 to January 10, 2020

• Relapse Free Survival

  Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first

  January 1, 2012 to January 10, 2020

• Best response

  Best response recorded from treatment start until disease progression/recurrence

  January 1, 2012 to January 10, 2020

• Time to best response

  Time from treatment initiation until best response recorded

  January 1, 2012 to January 10, 2020

• Duration of best response

  Time from best response achieved until lose of response or the end of the record, whichever occurs first

  January 1, 2012 to January 10, 2020

Study Arms (1)

AML

Patients diagnosed with AML

Drug: azacitidine; Drug: venetoclax; Drug: glasdegib

Interventions

azacitidine DRUG

Patients taking azacitidine

AML

venetoclax DRUG

patients taking venetoclax

AML

glasdegib DRUG

patients taking glasdegib

AML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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:
• AZA
• GLAS
• VEN
• Age ≥18 years at initial diagnosis of AML.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• \. 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.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax; glasdegib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: October 31, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 7, 2023

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share