Ireland
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Active, not recruiting Phase 2

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

NCT02966756 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 2
Started
2017-10-12
Last updated
2026-08-19

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Investigational drug(s) / intervention(s)

Venetoclax →

Venetoclax: Tablet; Oral

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 × 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 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.

Primary outcome measure(s)

  • Overall Response Rate (ORR) — Measured up to 2 years after the last participant has enrolled in the study.
    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).

Trial sites (31)

FacilityCityRegionStatus
Concord Repatriation General Hospital /ID# 201261 Concord New South Wales
St George Hospital - Kogarah /ID# 206484 Kogarah New South Wales
Monash Health - Monash Medical Centre - Clayton /ID# 201263 Clayton Victoria
Anhui Provincial Cancer Hospital /ID# 209458 Hefei Anhui
Peking University People's Hospital /ID# 156575 Beijing Beijing Municipality
Peking Union Medical College Hospital East - Dongdan Campus /ID# 156576 Beijing Beijing Municipality
Fujian Medical University Union Hospital /ID# 156579 Fuzhou Fujian
Guangdong Provincial Peoples Hospital /ID# 160509 Guangzhou Guangdong
Nanfang Hospital of Southern Medical University /ID# 156571 Guangzhou Guangdong
The Second Hospital of Hebei Medical University /ID# 159143 Shijiazhuang Hebei
Henan Cancer Hospital /ID# 156573 Zhengzhou Henan
Tongji Hospital Tongji Medical College of HUST /ID# 156589 Wuhan Hubei
Xiangya Hospital Central South University /ID# 208913 Changsha Hunan
Jiangsu Province Hospital /ID# 156577 Nanjing Jiangsu
The First Affiliated Hospital of Soochow University /ID# 156536 Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University /ID# 159142 Nanchang Jiangxi
The First Hospital of Jilin University /ID# 156532 Changchun Jilin
Shandong Provincial Hospital /ID# 156574 Jinan Shandong
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572 Shanghai Shanghai Municipality
West China Hospital, Sichuan University /ID# 156537 Chengdu Sichuan
The General Hospital of Western Theater Command PLA /ID# 159145 Chengdu Sichuan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762 Tianjin Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital /ID# 156542 Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578 Hangzhou Zhejiang
North Shore Hospital /ID# 204637 Takapuna Auckland
Christchurch Hospital. /ID# 201650 Christchurch Canterbury
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
National Taiwan University Hospital /ID# 210733 Taipei Taiwan
Linkou Chang Gung Memorial Hospital /ID# 203636 Taoyuan City Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02966756 on ClinicalTrials.gov ↗ ← All trials in China