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)

NCT04826523 | Completed

• 1 other identifier: P20-444
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia (AML); AML; Venetoclax; Venclexta; Venclyxto; Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  32 weeks

Secondary Outcomes (8)

• Percentage of Participants who Achieved Complete Remission (CR)

  28 weeks

• Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)

  28 weeks

• The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi)

  28 weeks

• Median Time to Achieve Complete Remission [CR] (month)

  28 weeks

• Median Time to Achieve CRi

  28 weeks

Study Arms (1)

Participants treated with Venetoclax

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Myeloid Leukemia (AML) participants who are prescribed Venetoclax within the approved label shall be enrolled in the study according to the clinical judgment of the physician in charge of the study.

You may qualify if:

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

You may not qualify if:

• Participants with contraindications to Venetoclax as listed on the approved local label.
• Participants receiving Venetoclax in clinical trials.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Pusan National University Hospital /ID# 239010

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Kosin University Gospel Hospital /ID# 257399

Busan, Busan Gwang Yeogsi, 49267, South Korea

Location

Kyungpook National University Hospital /ID# 257398

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Gachon University Gil Medical Center /ID# 239008

Incheon, Gyeonggido, 21565, South Korea

Location

Chonnam National University Hwasun Hospital /ID# 257478

Hwasun-gun, Jeonranamdo, 58128, South Korea

Location

Korea University Anam Hospital /ID# 231022

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Seoul National University Hospital /ID# 257477

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 239009

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Yeungnam University Medical Center /ID# 239007

Daegu, 42415, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 239006

Seoul, 03722, South Korea

Location

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: April 5, 2021
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

KR (10)