Actively Recruiting
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by AbbVie · Updated on 2025-12-24
110
Participants Needed
31
Research Sites
602 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma meeting 2008 Modified iwCLL NCI-WG Guidelines
- Indication for treatment according to 2008 Modified iwCLL NCI-WG Guidelines
- For SLL: measurable disease with B-lymphocytosis > 5 x 10^9/L, enlarged lymph nodes > 1.5 cm, hepatomegaly, or splenomegaly due to CLL
- For SLL: presence of lymphadenopathy without cytopenias caused by clonal marrow infiltrate
- Relapsed or refractory after at least one prior therapy
- Cohort 1 participants must have 17p deletion confirmed by central lab
- Cohort 2 participants must have relapsed/refractory disease to B-cell receptor inhibitor and either relapsed/refractory to chemoimmunotherapy or ineligible for chemoimmunotherapy due to 17p deletion, TP53 mutation, CIRS >6, creatinine clearance <70 mL/min, or investigator assessment
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- Adequate bone marrow, coagulation, kidney, and liver function
- No active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
You will not qualify if you...
- Previous allogeneic stem cell transplant
- Richter's transformation confirmed by biopsy
- Prolymphocytic leukemia
- Active and uncontrolled autoimmune cytopenias including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura within 2 weeks prior to screening
- Prior treatment with venetoclax or other BCL-2 inhibitors
- Known HIV positive status
- Received biologic anti-cancer agent within 30 days before first study dose
- Received chemotherapy, immunotherapy, radiotherapy, targeted agents, or investigational therapy within 14 days or 5 half-lives before first venetoclax dose without recovery to CTCAE grade <2 toxicity
- Allergy to both xanthine oxidase inhibitors and rasburicase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Concord Repatriation General Hospital /ID# 201261
Concord, New South Wales, Australia, 2139
Actively Recruiting
2
St George Hospital /ID# 206484
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
3
Monash Health - Monash Medical Centre /ID# 201263
Clayton, Victoria, Australia, 3168
Completed
4
Anhui Provincial Cancer Hospital /ID# 209458
Hefei, Anhui, China, 230031
Actively Recruiting
5
Peking University People's Hospital /ID# 156575
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
6
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
7
Fujian Medical University Union Hospital /ID# 156579
Fuzhou, Fujian, China, 350001
Actively Recruiting
8
Guangdong Provincial Peoples Hospital /ID# 160509
Guangzhou, Guangdong, China, 510080
Actively Recruiting
9
Nanfang Hospital of Southern Medical University /ID# 156571
Guangzhou, Guangdong, China, 510515
Actively Recruiting
10
The Second Hospital of Hebei Medical University /ID# 159143
Shijiazhuang, Hebei, China, 050000
Completed
11
Henan Cancer Hospital /ID# 156573
Zhengzhou, Henan, China, 450008
Actively Recruiting
12
Tongji Hospital Tongji Medical College of HUST /ID# 156589
Wuhan, Hubei, China, 430030
Actively Recruiting
13
Xiangya Hospital Central South University /ID# 208913
Changsha, Hunan, China, 410008
Actively Recruiting
14
Jiangsu Province Hospital /ID# 156577
Nanjing, Jiangsu, China, 210029
Actively Recruiting
15
The First Affiliated Hospital of Soochow University /ID# 156536
Suzhou, Jiangsu, China, 215006
Actively Recruiting
16
The First Affiliated Hospital of Nanchang University /ID# 159142
Nanchang, Jiangxi, China, 330006
Actively Recruiting
17
The First Hospital of Jilin University /ID# 156532
Changchun, Jilin, China, 130021
Actively Recruiting
18
Shandong Provincial Hospital /ID# 156574
Jinan, Shandong, China, 250021
Actively Recruiting
19
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
20
West China Hospital, Sichuan University /ID# 156537
Chengdu, Sichuan, China, 610041
Actively Recruiting
21
The General Hospital of Western Theater Command PLA /ID# 159145
Chengdu, Sichuan, China, 610083
Actively Recruiting
22
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
23
Tianjin Medical University Cancer Institute & Hospital /ID# 156542
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
24
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
25
North Shore Hospital /ID# 204637
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
26
Christchurch Hospital. /ID# 201650
Christchurch, Canterbury, New Zealand, 8011
Completed
27
National Taiwan University Hospital /ID# 210733
Taipei City, Taipei, Taiwan, 100
Actively Recruiting
28
Changhua Christian Hospital /ID# 202768
Changhua City, Changhua County, Taiwan, 50006
Completed
29
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765
Kaohsiung City, Taiwan, 807
Actively Recruiting
30
China Medical University Hospital /ID# 202767
Taichung, Taiwan, 40447
Actively Recruiting
31
Linkou Chang Gung Memorial Hospital /ID# 203636
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here