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
1 other identifier
interventional
110
4 countries
31
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2017
Longer than P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedStudy Start
First participant enrolled
October 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
December 24, 2025
December 1, 2025
11.6 years
November 15, 2016
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR is the proportion of participants with an overall response (complete remission \[CR\], plus complete remission with incomplete bone marrow recovery \[CRi\], plus nodular partial remission \[nPR\], plus partial remission \[PR\]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
Measured up to 2 years after the last participant has enrolled in the study.
Secondary Outcomes (7)
Complete Response Rate (CRR)
Measured up to 2 years after the last participant has enrolled into the study.
Duration of Overall Response (DOR)
Measured up to 2 years after the last participant has enrolled into the study.
Progression Free Survival (PFS)
Measured up to 5 years after the last participant has enrolled into the study.
Event Free Survival (EFS)
Measured up to 5 years after the last participant has enrolled into the study.
Time to Progression (TTP)
Measured up to 5 years after the last participant has enrolled into the study.
- +2 more secondary outcomes
Study Arms (2)
Cohort 1: Venetoclax
EXPERIMENTALParticipants with 17p deletion status will receive various doses of venetoclax once daily (QD).
Cohort 2: Venetoclax
EXPERIMENTALParticipants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).
Interventions
Tablet; Oral
Eligibility Criteria
You may qualify if:
- Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines and the following:
- Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines.
- SLL participant must have measurable disease (B-lymphocytosis greater than 5 Ă— 10\^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) \> 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL).
- SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
- Participant must have relapsed or refractory CLL/SLL after receiving at least one 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 to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) \>6 or calculated creatinine clearance \<70 mL/min, or participants in whom the investigator evaluated that the use of CIT was inappropriate.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening.
- No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
You may not qualify if:
- 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 to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic 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 days prior 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 recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
- Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents.
- Investigational therapy, including targeted small molecule agents.
- Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (31)
Concord Repatriation General Hospital /ID# 201261
Concord, New South Wales, 2139, Australia
St George Hospital /ID# 206484
Kogarah, New South Wales, 2217, Australia
Monash Health - Monash Medical Centre /ID# 201263
Clayton, Victoria, 3168, Australia
Anhui Provincial Cancer Hospital /ID# 209458
Hefei, Anhui, 230031, China
Peking University People's Hospital /ID# 156575
Beijing, Beijing Municipality, 100044, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital /ID# 156579
Fuzhou, Fujian, 350001, China
Guangdong Provincial Peoples Hospital /ID# 160509
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 156571
Guangzhou, Guangdong, 510515, China
The Second Hospital of Hebei Medical University /ID# 159143
Shijiazhuang, Hebei, 050000, China
Henan Cancer Hospital /ID# 156573
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical College of HUST /ID# 156589
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University /ID# 208913
Changsha, Hunan, 410008, China
Jiangsu Province Hospital /ID# 156577
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University /ID# 156536
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University /ID# 159142
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University /ID# 156532
Changchun, Jilin, 130021, China
Shandong Provincial Hospital /ID# 156574
Jinan, Shandong, 250021, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572
Shanghai, Shanghai Municipality, 200065, China
West China Hospital, Sichuan University /ID# 156537
Chengdu, Sichuan, 610041, China
The General Hospital of Western Theater Command PLA /ID# 159145
Chengdu, Sichuan, 610083, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute & Hospital /ID# 156542
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578
Hangzhou, Zhejiang, 310003, China
North Shore Hospital /ID# 204637
Takapuna, Auckland, 0622, New Zealand
Christchurch Hospital. /ID# 201650
Christchurch, Canterbury, 8011, New Zealand
National Taiwan University Hospital /ID# 210733
Taipei City, Taipei, 100, Taiwan
Changhua Christian Hospital /ID# 202768
Changhua City, Changhua County, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765
Kaohsiung City, 807, Taiwan
China Medical University Hospital /ID# 202767
Taichung, 40447, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 203636
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 17, 2016
Study Start
October 12, 2017
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.