Evaluating the safety and effectiveness of oral venetoclax in adults with Acute Myeloid Leukemia
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
This study is testing if taking oral venetoclax can safely help adults with Acute Myeloid Leukemia feel better and manage their disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 10 sites (Busan, Busan Gwang Yeogsi and 9 other locations) |
| Trial ID | NCT04826523 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and effectiveness of oral venetoclax tablets in adults diagnosed with Acute Myeloid Leukemia (AML). Approximately 600 participants aged 19 and older will be enrolled across multiple medical institutions in South Korea. Participants will receive venetoclax as prescribed by their physicians and will be monitored for adverse events and changes in disease activity over seven 28-day cycles. The study aims to gather data under routine clinical practice conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who have been prescribed oral venetoclax for the first time.
Not a fit: Patients who have contraindications to venetoclax or are currently participating in other clinical trials involving venetoclax may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of venetoclax for treating AML, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown positive outcomes with venetoclax in treating AML, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Busan, Busan Gwang Yeogsi and 9 other locations
- Kosin University Gospel Hospital /ID# 257399 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Kyungpook National University Hospital /ID# 257398 — 중구, Daegu Gwang Yeogsi, Korea, Republic of (Recruiting)
- Gachon University Gil Medical Center /ID# 239008 — Incheon, Gyeonggido, Korea, Republic of (Recruiting)
- Chonnam National University Hwasun Hospital /ID# 257478 — Hwasun-gun, Jeonranamdo, Korea, Republic of (Recruiting)
- Yonsei University Health System Severance Hospital /ID# 239006 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- Pusan National University Hospital /ID# 239010 — Busan, Korea, Republic of (Recruiting)
- Yeungnam University Medical Center /ID# 239007 — Daegu, Korea, Republic of (Completed)
- Korea University Anam Hospital /ID# 231022 — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital /ID# 257477 — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center /ID# 239009 — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.