Clinical trial NCT04178317: A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice
Official title: Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer, Chronic Lymphocytic Leukemia (CLL)
Keywords: Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic lymphocytic leukemia (CLL) who are prescribed venetoclax within the approved label according to physician judgement.

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to Approximately 7 Years
Secondary outcomes:
measure: Overall Response
timeFrame: Up to Approximately 7 Years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 233882
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 216850
state: Busan Gwang Yeogsi
city: 중구
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 233884
state: Daegu Gwang Yeogsi
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea st. Paul's hospital /ID# 238907
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 249512
state: Gyeonggido
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 216849
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 216851
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 216853
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 217180
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 215348
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: