Phase
Condition
Leukemia
Lymphocytic Leukemia, Chronic
Lymphoma
Treatment
Venetoclax
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have a diagnosis of relapsed or refractory chronic lymphocyticleukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 ModifiedInternational Workshop for Chronic Lymphocytic Leukemia (iwCLL) National CancerInstitute-Working Group (NCI-WG) Guidelines and the following:
Participant must have an indication for treatment according to the 2008Modified iwCLL NCI-WG Guidelines.
SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) > 1.5 cm atbaseline) or hepatomegaly or splenomegaly due to CLL).
SLL participant must have presence of lymphadenopathy and absence of cytopeniascaused by a clonal marrow infiltrate.
Participant must have relapsed or refractory CLL/SLL after receiving at leastone prior line of therapy.
Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.
Participants (in Cohort 2) must meet both of the following:
Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment;
And either of the following: (a) relapsed/refractory disease tochemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as havingknown 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) >6 or calculated creatinine clearance <70 mL/min, or participants in whom theinvestigator evaluated that the use of CIT was inappropriate.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance scoreof less than or equal to 2.
Participant must have adequate bone marrow function, coagulation profile, renal, andhepatic function, per laboratory reference range at Screening.
No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection.
Exclusion
Exclusion Criteria:
Participant has undergone an allogeneic stem cell transplant.
Participant has developed Richter's transformation confirmed by biopsy.
Participant has prolymphocytic leukemia.
Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior toscreening), including autoimmune hemolytic anemia (AIHA) and idiopathicthrombocytopenic purpura (ITP).
Participant has previously received venetoclax or other BCL-2 inhibitors.
Participant is known to be positive for Human Immunodeficiency Virus (HIV).
Participant has received a biologic agent for anti-neoplastic intent within 30 daysprior to the first dose of study drug.
Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of venetoclax, or has not recoveredto less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinicallysignificant adverse effect(s)/toxicity(s) of the previous therapy:
Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy ortargeted small molecule agents.
Investigational therapy, including targeted small molecule agents.
Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.
Study Design
Connect with a study center
The Canberra Hospital /ID# 201262
Garran, Australian Capital Territory 2605
AustraliaSite Not Available
Concord Repatriation General Hospital /ID# 201261
Concord, New South Wales 2139
AustraliaActive - Recruiting
St George Hospital /ID# 206484
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre /ID# 201263
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Medical Centre /ID# 201263
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Medical Centre /ID# 201263
Melbourne, Victoria 3168
AustraliaSite Not Available
Anhui Provincial Cancer Hospital /ID# 209458
Hefei, Anhui 230031
ChinaActive - Recruiting
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576
Beijing, Beijing 100730
ChinaActive - Recruiting
Peking Union Medical College Hospital /ID# 156576
Beijing, Beijing 100730
ChinaActive - Recruiting
Peking University People's Hospital /ID# 156575
Beijing, Beijing 100044
ChinaActive - Recruiting
Xinqiao Hospital of 3rd Military Medical University /ID# 209114
Chongqing, Chongqing 400037
ChinaSite Not Available
Fujian Medical University Union Hospital /ID# 156579
Fuzhou, Fujian 350001
ChinaActive - Recruiting
Guangdong Provincial People's Hospital /ID# 160509
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
Nanfang Hospital of Southern Medical University /ID# 156571
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
The Second Hospital of Hebei Medical University /ID# 159143
Shijiazhuang, Hebei 050000
ChinaCompleted
Henan Cancer Hospital /ID# 156573
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Tongji Hospital Tongji Medical College of HUST /ID# 156589
Wuhan, Hubei 430030
ChinaActive - Recruiting
Xiangya Hospital Central South University /ID# 208913
Changsha, Hunan 410008
ChinaActive - Recruiting
Jiangsu Province Hospital /ID# 156577
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University /ID# 156536
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University /ID# 159142
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
The First Hospital of Jilin University /ID# 156532
Changchun, Jilin 130021
ChinaActive - Recruiting
Shandong Provincial Hospital /ID# 156574
Jinan, Shandong 250021
ChinaActive - Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572
Shanghai, Shanghai 200065
ChinaActive - Recruiting
The General Hospital of Western Theater Command PLA /ID# 159145
Chengdu, Sichuan 610083
ChinaActive - Recruiting
West China Hospital, Sichuan University /ID# 156537
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762
Tianjin, Tianjin 300020
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute & Hospital /ID# 156542
Tianjin, Tianjin 300060
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Chengdu Military General Hosp /ID# 159145
Chengdu, Sichuan, 610083
ChinaSite Not Available
Fujian Medical University Union Hospital /ID# 156579
Fuzhou, Fujian Province, 350001
ChinaSite Not Available
1st Affiliated Hospital College of Medicine, Zhejiang Univ /ID# 156578
Hangzhou, Zhejiang Province, 310003
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University /ID# 159142
Nanchang, Jiangxi Province, 330006
ChinaSite Not Available
The First Affiliated Hospital of Soochow University /ID# 156536
Soochow, 215006
ChinaSite Not Available
Subei People's Hospital /ID# 159141
Yangzhou, 225001
ChinaSite Not Available
Henan Cancer Hospital /ID# 156573
Zhengzhou Henan, 450008
ChinaSite Not Available
Henan Cancer Hospital /ID# 156573
Zhengzhou, Henan, 450008
ChinaSite Not Available
Henan Cancer Hospital /ID# 156573
Zhengzhou, Henan Province, 450008
ChinaSite Not Available
North Shore Hospital /ID# 204637
Takapuna, Auckland 0622
New ZealandActive - Recruiting
Christchurch Hospital /ID# 201650
Christchurch, Canterbury 8011
New ZealandActive - Recruiting
North Shore Hospital /ID# 204637
Auckland, 0622
New ZealandSite Not Available
Dunedin Hospital
Dunedin, 9016
New ZealandSite Not Available
National Taiwan University Hospital /ID# 210733
Taipei City, Taipei 100
TaiwanActive - Recruiting
Changhua Christian Hospital /ID# 202768
Changhua City, Changhua County, 50006
TaiwanCompleted
Changhua Christian Hospital /ID# 202768
Changhua County, 50006
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765
Kaohsiung, 807
TaiwanActive - Recruiting
Kaohsiung Medical University
Kaohsiung City, 807
TaiwanSite Not Available
China Medical University Hospital /ID# 202767
Taichung, 40447
TaiwanActive - Recruiting
China Medical University Hospital /ID# 202767
Taichung City, 40447
TaiwanSite Not Available
Chang Gung Memorial Hospital /ID# 203636
Taoyuan, 33305
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital /ID# 203636
Taoyuan City, 333
TaiwanActive - Recruiting
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