Cancer, Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients
| NCT number | NCT04178317 |
| Other study ID # | P19-942 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2, 2020 |
| Est. completion date | September 30, 2025 |
| Verified date | June 2024 |
| Source | AbbVie |
| Contact | HyeYeon Kim |
| Phone | +82 2 3429 9241 |
| kim.hyeyeon[@]abbvie.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | September 30, 2025 |
| Est. primary completion date | September 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kyungpook National University Hospital /ID# 233884 | ?? | Daegu Gwang Yeogsi |
| Korea, Republic of | Inje University - Busan Paik Hospital /ID# 233882 | Busan | Busan Gwang Yeogsi |
| Korea, Republic of | Pusan National University Hospital /ID# 216850 | Busan | |
| Korea, Republic of | Chonnam National University Hwasun Hospital /ID# 216849 | Hwasun-gun | Jeonranamdo |
| Korea, Republic of | Korea University Anam Hospital /ID# 216851 | Seoul | |
| Korea, Republic of | Samsung Medical Center /ID# 217180 | Seoul | |
| Korea, Republic of | Seoul National University Hospital /ID# 216853 | Seoul | |
| Korea, Republic of | The catholic university of korea st. Paul's hospital /ID# 238907 | Seoul | Gyeonggido |
| 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 | |
| Korea, Republic of | Yonsei University Health System Severance Hospital /ID# 215348 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Ajou University Hospital /ID# 249512 | Suwon-si | Gyeonggido |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. | Up to Approximately 7 Years | |
| Secondary | Overall Response | 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. | Up to Approximately 7 Years |