Acute Myeloid Leukemia Real World Treatment Patterns

Withdrawn

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: azacitidine; Drug: venetoclax; Drug: glasdegib

• Registration Number: NCT04230564
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-10-31
• Status Verified: 2021-02
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AML	glasdegib	Patients diagnosed with AML
AML	azacitidine	Patients diagnosed with AML
AML	venetoclax	Patients diagnosed with AML

Primary Outcome Measures

Name	Time	Method
Overall Survival	January 1, 2012 to January 10, 2020	Overall survival was the duration from diagnosis of disease to death.
Relapse Free Survival	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
Time to best response	January 1, 2012 to January 10, 2020	Time from treatment initiation until best response recorded
Event Free Survival	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
Best response	January 1, 2012 to January 10, 2020	Best response recorded from treatment start until disease progression/recurrence
Duration of best response	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