Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

NCT ID: NCT04826523

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-05

Study Completion Date

2025-10-20

Brief Summary

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Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea.

Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Detailed Description

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Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants treated with Venetoclax

Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

--Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.

Exclusion Criteria

* Participants with contraindications to Venetoclax as listed on the approved local label.
* Participants receiving Venetoclax in clinical trials.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Pusan National University Hospital /ID# 239010

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Kosin University Gospel Hospital /ID# 257399

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Kyungpook National University Hospital /ID# 257398

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Gachon University Gil Medical Center /ID# 239008

Incheon, Gyeonggido, South Korea

Site Status

Chonnam National University Hwasun Hospital /ID# 257478

Hwasun-gun, Jeonranamdo, South Korea

Site Status

Korea University Anam Hospital /ID# 231022

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Seoul National University Hospital /ID# 257477

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 239009

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Yeungnam University Medical Center /ID# 239007

Daegu, , South Korea

Site Status

Yonsei University Health System Severance Hospital /ID# 239006

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P20-444

Identifier Type: -

Identifier Source: org_study_id

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