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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Center-Based Chart Review Study to Assess Treatment Outcomes of Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06362031
• Other study ID #: H18.Oncology.12-SR1812
• Status: Withdrawn
• Start date: June 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS will be measured as the number of days between the initiation of the studied line of therapy and death.	Up to 10 Months
Primary	Event-free survival (EFS)	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.	Up to 10 Months
Primary	Percentage of Participants Achieving Best Overall Response	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.	Up to 10 Months
Primary	Duration of Response (DoR)	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.	Up to 10 Months
Primary	Percentage of Participants with Transfusion Independence (TI)	TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy.	Up to 10 Months
Secondary	Number of Participants with Healthcare Resource Utilization (HRU)	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.	Up to 10 Months

External Links

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