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A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice

Recruiting
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
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
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Exclusion Criteria

-Participants with contraindications to venetoclax as listed on the approved local label

Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse EventsUp 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
NameTimeMethod
Overall ResponseUp 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

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Busan, Busan Gwang Yeogsi, Korea, Republic of

Pusan National University Hospital /ID# 216850

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Busan, Busan Gwang Yeogsi, Korea, Republic of

Kyungpook National University Hospital /ID# 233884

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중구, Daegu Gwang Yeogsi, Korea, Republic of

The catholic university of korea st. Paul's hospital /ID# 238907

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Seoul, Gyeonggido, Korea, Republic of

Ajou University Hospital /ID# 249512

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Suwon-si, Gyeonggido, Korea, Republic of

Chonnam National University Hwasun Hospital /ID# 216849

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Hwasun-gun, Jeonranamdo, Korea, Republic of

Korea University Anam Hospital /ID# 216851

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

Seoul National University Hospital /ID# 216853

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 217180

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179

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Seoul, Seoul Teugbyeolsi, Korea, Republic of

Yonsei University Health System Severance Hospital /ID# 215348

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Seoul, Korea, Republic of

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