Actively Recruiting
A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by AbbVie · Updated on 2025-12-24
110
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy of venetoclax in adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This Phase 2, open-label, multicenter study focuses on two groups: those with 17p deletion (Cohort 1) and those who have failed B-cell receptor signaling pathway inhibitor therapy and either failed or cannot receive chemoimmunotherapy regardless of 17p status (Cohort 2). Participants in both cohorts will receive various doses of venetoclax tablets taken once daily. The study does not involve a placebo group and uses a non-randomized approach. Treatment is tailored based on the participant's disease characteristics and prior therapy history. During the study, researchers will monitor participants closely, assessing overall response rate up to two years after enrollment ends. Secondary measures include complete response rate, duration of response, progression-free survival, event-free survival, time to progression, time to lymphocyte count reduction, and overall survival, with some measures tracked up to five years. Participants will undergo regular evaluations to measure treatment effects and safety throughout the study.
CONDITIONS
Brief 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...
- Adults 18 years or older
- Diagnosis of relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) according to 2008 Modified iwCLL NCI-WG Guidelines
- Indication for treatment per 2008 Modified iwCLL NCI-WG Guidelines
- For SLL: measurable disease with B-lymphocytosis > 5 x 10^9/L or enlarged lymph node > 1.5 cm, hepatomegaly, or splenomegaly due to CLL
- For SLL: presence of lymphadenopathy and no cytopenias caused by clonal marrow infiltrate
- Relapsed or refractory after at least one prior therapy
- Cohort 1: presence of 17p deletion confirmed by central lab
- Cohort 2: relapsed/refractory to B-cell receptor signaling pathway inhibitor therapy and either relapsed/refractory to chemoimmunotherapy or ineligible for chemoimmunotherapy due to specific medical conditions or investigator assessment
- ECOG performance score ≤ 2
- Adequate bone marrow, coagulation, kidney, and liver function at screening
- No active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
You will not qualify if you...
- Prior 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
- Previous treatment with venetoclax or other BCL-2 inhibitors
- Human Immunodeficiency Virus (HIV) positive
- Received biologic agent for anti-cancer intent within 30 days before first dose
- Received anti-cancer therapy, investigational therapy, or targeted agents within 14 days or 5 half-lives before first dose and not recovered to less than CTCAE grade 2 toxicity
- Known allergy to both xanthine oxidase inhibitors and rasburicase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years depending on participant response and study duration
Participants receive venetoclax tablets orally once daily as treatment for their relapsed or refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Regular visits for treatment and monitoring as per protocol
Duration - Up to 5 years after last treatment dose
Participants are monitored for long-term outcomes including overall response, progression free survival, and overall survival after completing treatment.
Periodic visits for up to 5 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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