Acute Myeloid Leukemia Real World Treatment Patterns

Leukemia, Myeloid, Acute Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04230564
• Other study ID #: B1371038
• Status: Withdrawn
• Start date: October 31, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• azacitidine
Patients taking azacitidine
• venetoclax
patients taking venetoclax
• glasdegib
patients taking glasdegib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival was the duration from diagnosis of disease to death.	January 1, 2012 to January 10, 2020
Primary	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
Primary	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
Primary	Best response	Best response recorded from treatment start until disease progression/recurrence	January 1, 2012 to January 10, 2020
Primary	Time to best response	Time from treatment initiation until best response recorded	January 1, 2012 to January 10, 2020
Primary	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