A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT ID: NCT02966756
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2017-10-12
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Venetoclax
Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).
Venetoclax
Tablet; Oral
Cohort 2: Venetoclax
Participants 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).
Venetoclax
Tablet; Oral
Interventions
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Venetoclax
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 × 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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, , Taiwan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M14-728
Identifier Type: -
Identifier Source: org_study_id