Evaluating the safety and effectiveness of Venetoclax for chronic lymphocytic leukemia patients
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients
This study is testing how safe and effective the medication Venetoclax is for people with chronic lymphocytic leukemia who are starting treatment for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 13 sites (Busan, Busan Gwang Yeogsi and 12 other locations) |
| Trial ID | NCT04178317 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of Venetoclax in patients diagnosed with chronic lymphocytic leukemia (CLL) who are receiving the medication in routine clinical practice. Participants will be those who have been prescribed Venetoclax for the first time according to the approved label. The study will gather data on patient outcomes and experiences to better understand the drug's performance in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with chronic lymphocytic leukemia who are starting treatment with Venetoclax for the first time.
Not a fit: Patients who have contraindications to Venetoclax or are not diagnosed with chronic lymphocytic leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Venetoclax for CLL patients in everyday clinical practice.
How similar studies have performed: Other studies have shown promising results with Venetoclax in treating CLL, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants diagnosed with chronic lymphocytic leukemia who have been prescribed Venetoclax for the first time according to the approved label * Participants (and/or legal representative) who voluntarily agree to participate in this study and sign informed consent Exclusion Criteria: -Participants with contraindications to venetoclax as listed on the approved local label
Where this trial is running
Busan, Busan Gwang Yeogsi and 12 other locations
- Inje University - Busan Paik Hospital /ID# 233882 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Pusan National University Hospital /ID# 216850 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Kyungpook National University Hospital /ID# 233884 — 중구, Daegu Gwang Yeogsi, Korea, Republic of (Recruiting)
- The catholic university of korea st. Paul's hospital /ID# 238907 — Seoul, Gyeonggido, Korea, Republic of (Recruiting)
- Ajou University Hospital /ID# 249512 — Suwon-si, Gyeonggido, Korea, Republic of (Recruiting)
- Chonnam National University Hwasun Hospital /ID# 216849 — Hwasun-gun, Jeonranamdo, Korea, Republic of (Recruiting)
- Korea University Anam Hospital /ID# 216851 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- Seoul National University Hospital /ID# 216853 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- Samsung Medical Center /ID# 217180 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Completed)
- The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (Recruiting)
- Yonsei University Health System Severance Hospital /ID# 215348 — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: HyeYeon Kim
- Email: kim.hyeyeon@abbvie.com
- Phone: +82 2 3429 9241
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.