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

NCT06362031 | Withdrawn

• 1 other identifier: H18.Oncology.12-SR1812
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Cancer; Venetoclax: Venclyxto; ABT-199

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Participants with Healthcare Resource Utilization (HRU)

  Up to 10 Months

Study Arms (1)

Participants Receiving Venetoclax

Participants with AML receiving venetoclax undergoing chart review.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Participants with Acute Myeloid Leukemia (AML) being treated with venetoclax.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: April 12, 2024
• Study Start: June 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share