A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Last updated: April 30, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Lymphocytic Leukemia, Chronic

Lymphoma

Treatment

Venetoclax

Clinical Study ID

NCT02966756
M14-728
  • Ages > 18
  • All Genders

Study 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).

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

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Venetoclax
Phase: 2
Study Start date:
October 12, 2017
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • The Canberra Hospital /ID# 201262

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Concord Repatriation General Hospital /ID# 201261

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • St George Hospital /ID# 206484

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 201263

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 201263

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 201263

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • Anhui Provincial Cancer Hospital /ID# 209458

    Hefei, Anhui 230031
    China

    Active - Recruiting

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Peking Union Medical College Hospital /ID# 156576

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Peking University People's Hospital /ID# 156575

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Xinqiao Hospital of 3rd Military Medical University /ID# 209114

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • Fujian Medical University Union Hospital /ID# 156579

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital /ID# 160509

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Nanfang Hospital of Southern Medical University /ID# 156571

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University /ID# 159143

    Shijiazhuang, Hebei 050000
    China

    Completed

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College of HUST /ID# 156589

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Xiangya Hospital Central South University /ID# 208913

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • Jiangsu Province Hospital /ID# 156577

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University /ID# 156536

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University /ID# 159142

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Hospital of Jilin University /ID# 156532

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Shandong Provincial Hospital /ID# 156574

    Jinan, Shandong 250021
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572

    Shanghai, Shanghai 200065
    China

    Active - Recruiting

  • The General Hospital of Western Theater Command PLA /ID# 159145

    Chengdu, Sichuan 610083
    China

    Active - Recruiting

  • West China Hospital, Sichuan University /ID# 156537

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital /ID# 156542

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Chengdu Military General Hosp /ID# 159145

    Chengdu, Sichuan, 610083
    China

    Site Not Available

  • Fujian Medical University Union Hospital /ID# 156579

    Fuzhou, Fujian Province, 350001
    China

    Site Not Available

  • 1st Affiliated Hospital College of Medicine, Zhejiang Univ /ID# 156578

    Hangzhou, Zhejiang Province, 310003
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University /ID# 159142

    Nanchang, Jiangxi Province, 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University /ID# 156536

    Soochow, 215006
    China

    Site Not Available

  • Subei People's Hospital /ID# 159141

    Yangzhou, 225001
    China

    Site Not Available

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou Henan, 450008
    China

    Site Not Available

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou, Henan, 450008
    China

    Site Not Available

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou, Henan Province, 450008
    China

    Site Not Available

  • North Shore Hospital /ID# 204637

    Takapuna, Auckland 0622
    New Zealand

    Active - Recruiting

  • Christchurch Hospital /ID# 201650

    Christchurch, Canterbury 8011
    New Zealand

    Active - Recruiting

  • North Shore Hospital /ID# 204637

    Auckland, 0622
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin, 9016
    New Zealand

    Site Not Available

  • National Taiwan University Hospital /ID# 210733

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Changhua Christian Hospital /ID# 202768

    Changhua City, Changhua County, 50006
    Taiwan

    Completed

  • Changhua Christian Hospital /ID# 202768

    Changhua County, 50006
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 202767

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 202767

    Taichung City, 40447
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital /ID# 203636

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 203636

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

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