Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients

Status: Completed
Location: See all (10) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

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

Locations
Other Locations
Republic of Korea
Kosin University Gospel Hospital /ID# 257399
Busan
Pusan National University Hospital /ID# 239010
Busan
Kyungpook National University Hospital /ID# 257398
Daegu
Yeungnam University Medical Center /ID# 239007
Daegu
Chonnam National University Hwasun Hospital /ID# 257478
Hwasun-gun
Gachon University Gil Medical Center /ID# 239008
Incheon
Korea University Anam Hospital /ID# 231022
Seoul
Samsung Medical Center /ID# 239009
Seoul
Seoul National University Hospital /ID# 257477
Seoul
Yonsei University Health System Severance Hospital /ID# 239006
Seoul
Time Frame
Start Date: 2021-04-05
Completion Date: 2025-10-20
Participants
Target number of participants: 150
Treatments
Participants treated with Venetoclax
Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov