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

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

In brief

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).

Key facts

Study ID: NCT02966756
Run by: AbbVie
People needed: 110
Starts: 2017-10-12
Expected to finish: 2029-05-01
Last updated by the study team: 2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 × 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.

Where it is running

Linkou Chang Gung Memorial Hospital /ID# 203636 — Taoyuan City, Taiwan (enrolling)
St George Hospital /ID# 206484 — Kogarah, New South Wales, Australia (enrolling)
National Taiwan University Hospital /ID# 210733 — Taipei City, Taipei, Taiwan (enrolling)
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765 — Kaohsiung City, Taiwan (enrolling)
China Medical University Hospital /ID# 202767 — Taichung, Taiwan (enrolling)
Concord Repatriation General Hospital /ID# 201261 — Concord, New South Wales, Australia (enrolling)
Anhui Provincial Cancer Hospital /ID# 209458 — Hefei, Anhui, China (enrolling)
Peking University People's Hospital /ID# 156575 — Beijing, Beijing Municipality, China (enrolling)
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 156576 — Beijing, Beijing Municipality, China (enrolling)
Fujian Medical University Union Hospital /ID# 156579 — Fuzhou, Fujian, China (enrolling)
Guangdong Provincial Peoples Hospital /ID# 160509 — Guangzhou, Guangdong, China (enrolling)
Nanfang Hospital of Southern Medical University /ID# 156571 — Guangzhou, Guangdong, China (enrolling)
Henan Cancer Hospital /ID# 156573 — Zhengzhou, Henan, China (enrolling)
Tongji Hospital Tongji Medical College of HUST /ID# 156589 — Wuhan, Hubei, China (enrolling)
Xiangya Hospital Central South University /ID# 208913 — Changsha, Hunan, China (enrolling)
Jiangsu Province Hospital /ID# 156577 — Nanjing, Jiangsu, China (enrolling)
The First Affiliated Hospital of Soochow University /ID# 156536 — Suzhou, Jiangsu, China (enrolling)
The First Affiliated Hospital of Nanchang University /ID# 159142 — Nanchang, Jiangxi, China (enrolling)
The First Hospital of Jilin University /ID# 156532 — Changchun, Jilin, China (enrolling)
Shandong Provincial Hospital /ID# 156574 — Jinan, Shandong, China (enrolling)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572 — Shanghai, Shanghai Municipality, China (enrolling)
West China Hospital, Sichuan University /ID# 156537 — Chengdu, Sichuan, China (enrolling)
The General Hospital of Western Theater Command PLA /ID# 159145 — Chengdu, Sichuan, China (enrolling)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762 — Tianjin, Tianjin Municipality, China (enrolling)
Tianjin Medical University Cancer Institute & Hospital /ID# 156542 — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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