RecruitingPhase 2NCT02966756

A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor

AbbVie

Enrollment

110 participants

Start Date

Oct 12, 2017

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Summary

This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called venetoclax in patients with a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with CLL or SLL that has relapsed (come back) or is no longer responding to treatment - Your cancer meets certain criteria for needing treatment based on international guidelines - You have not received venetoclax before - You are in generally good enough health to participate, with adequate organ function **You may NOT be eligible if...** - You have certain chromosomal abnormalities that make this treatment less likely to work - You have significant other health problems, like serious infections or uncontrolled autoimmune conditions - You have received too many prior treatments or the wrong types of prior treatments for this study - You are pregnant or breastfeeding - You are taking certain medications that could interact dangerously with venetoclax Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Tablet; Oral

Locations(31)

Concord Repatriation General Hospital /ID# 201261

Concord, New South Wales, Australia

St George Hospital /ID# 206484

Kogarah, New South Wales, Australia

Monash Health - Monash Medical Centre /ID# 201263

Clayton, Victoria, Australia

Anhui Provincial Cancer Hospital /ID# 209458

Hefei, Anhui, China

Peking University People's Hospital /ID# 156575

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital /ID# 156579

Fuzhou, Fujian, China

Guangdong Provincial Peoples Hospital /ID# 160509

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University /ID# 156571

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University /ID# 159143

Shijiazhuang, Hebei, China

Henan Cancer Hospital /ID# 156573

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical College of HUST /ID# 156589

Wuhan, Hubei, China

Xiangya Hospital Central South University /ID# 208913

Changsha, Hunan, China

Jiangsu Province Hospital /ID# 156577

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University /ID# 156536

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University /ID# 159142

Nanchang, Jiangxi, China

The First Hospital of Jilin University /ID# 156532

Changchun, Jilin, China

Shandong Provincial Hospital /ID# 156574

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University /ID# 156537

Chengdu, Sichuan, China

The General Hospital of Western Theater Command PLA /ID# 159145

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital /ID# 156542

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578

Hangzhou, Zhejiang, China

North Shore Hospital /ID# 204637

Takapuna, Auckland, New Zealand

Christchurch Hospital. /ID# 201650

Christchurch, Canterbury, New Zealand

National Taiwan University Hospital /ID# 210733

Taipei City, Taipei, Taiwan

Changhua Christian Hospital /ID# 202768

Changhua City, Changhua County, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765

Kaohsiung City, Taiwan

China Medical University Hospital /ID# 202767

Taichung, Taiwan

Linkou Chang Gung Memorial Hospital /ID# 203636

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

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