A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review

Withdrawn

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT06362031
• Lead Sponsor: AbbVie

Brief Summary

Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.

Data from up to 700 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study Start: 2023-06-01
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• The participant received a diagnosis for acute myeloid leukemia (AML).
• The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol.
• The participant was treated with the studied line of therapy at least 28 days prior to date of data collection.
• Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.

Exclusion Criteria

• The participant received the studied line of therapy as part of a clinical trial.
• Participant received prior lines of therapy for AML.
• The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	Up to 10 Months	EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death.
Duration of Response (DoR)	Up to 10 Months	DoR is is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi), complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS); in days.
Overall Survival (OS)	Up to 10 Months	OS will be measured as the number of days between the initiation of the studied line of therapy and death.
Percentage of Participants with Transfusion Independence (TI)	Up to 10 Months	TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy.
Percentage of Participants Achieving Best Overall Response	Up to 10 Months	Physician-reported best response achieved from initiation of the studied line of therapy until the earliest of disease progression, refractory disease, relapse, switch to a new line of therapy, or end of follow-up or death.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Healthcare Resource Utilization (HRU)	Up to 10 Months	HRU is measured from initiation of the studied line of therapy until physician recorded disease progression, refractory disease, relapse, or switch to a new line of therapy.