A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice
- Conditions
- Cancer, Chronic Lymphocytic Leukemia (CLL)
- Registration Number
- NCT04178317
- Lead Sponsor
- AbbVie
- Brief Summary
This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
-Participants with contraindications to venetoclax as listed on the approved local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Up to Approximately 7 Years An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
- Secondary Outcome Measures
Name Time Method Overall Response Up to Approximately 7 Years Overall Response will be assessed by the physician in charge of the study in accordance with the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.
Trial Locations
- Locations (13)
Inje University - Busan Paik Hospital /ID# 233882
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Pusan National University Hospital /ID# 216850
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Kyungpook National University Hospital /ID# 233884
🇰🇷중구, Daegu Gwang Yeogsi, Korea, Republic of
The catholic university of korea st. Paul's hospital /ID# 238907
🇰🇷Seoul, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 249512
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 216849
🇰🇷Hwasun-gun, Jeonranamdo, Korea, Republic of
Korea University Anam Hospital /ID# 216851
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 216853
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 217180
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 215348
🇰🇷Seoul, Korea, Republic of