A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.

Key facts

Study ID

NCT02756611

Run by

AbbVie

People needed

258

Starts

2016-06-22

Expected to finish

2022-03-11

Last updated by the study team

2023-04-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
• Participant has relapsed/refractory disease (received at least 1 prior therapy)
• Participant has diagnosis of CLL that meets published 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines and:
• has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
• has clinically measurable disease (lymphocytosis greater than 5 × 10\^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
• In addition, participants:
• with or without 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood are eligible
• may have been previously treated with a prior B-cell receptor inhibitor
• Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory at Screening

You may not qualify if…

• Participant has developed Richter's transformation or Prolymphocytic leukemia
• Participant has previously received venetoclax
• History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
• adequately treated in situ carcinoma of the cervix uteri
• adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
• previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
• Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
• Participant has undergone an allogeneic stem cell transplant
• Treatment with any of the following within five half-lives or 14 days (if half-life unknown) as applicable prior to the first dose of venetoclax, or clinically significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to < National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade 2:
• Any anti-cancer therapy including chemotherapy, or radiotherapy;
• Investigational therapy, including targeted small molecule agents
• Participant is human immunodeficiency virus (HIV) positive
• Participant has known allergy to both xanthine oxidase inhibitors and rasburicase

Where it is running

• St. Agnes Cancer Center /ID# 149782 — Baltimore, Maryland, United States
• Hackensack Univ Med Ctr /ID# 151574 — Hackensack, New Jersey, United States
• Utah Cancer Specialists /ID# 151604 — Salt Lake City, Utah, United States
• Cancer Care Northwest /ID# 151605 — Spokane, Washington, United States
• West Virginia Univ School Med /ID# 151602 — Morgantown, West Virginia, United States
• LKH-Univ. Klinikum Graz /ID# 147547 — Graz, Austria
• LKH Salzburg and Paracelsus /ID# 147549 — Salzburg, Austria
• Hanusch Krankenhaus der WGKK /ID# 147548 — Vienna, Austria
• Cliniques Universitaires Saint Luc /ID# 147388 — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• UZ Leuven /ID# 147387 — Leuven, Belgium
• BC Cancer Agency /ID# 153091 — Vancouver, British Columbia, Canada
• Qe Ii Hsc /Id# 147460 — Halifax, Nova Scotia, Canada
• Juravinski Cancer Clinic /ID# 149152 — Hamilton, Ontario, Canada
• Sunnybrook Health Sciences Ctr /ID# 147462 — Toronto, Ontario, Canada
• CHU de Quebec-Universite Laval /ID# 150299 — Québec, Quebec, Canada
• Herlev Hospital /ID# 150183 — Herlev, Capital Region, Denmark
• Aarhus University Hospital /ID# 147409 — Aarhus N, Central Jutland, Denmark
• Turku University Hospital /ID# 147551 — Turku, Finland
• CHU Dupuytren /ID# 147552 — Limoges, Franche-Comte, France
• CHU de la miletrie /ID# 147484 — Poitiers, Poitou-Charentes, France
• Institut Bergonie /ID# 147482 — Bordeaux, France
• CHRU de Brest - Hopital Morvan /ID# 147485 — Brest, France
• clinique Sainte Anne /ID# 147556 — Strasbourg, France
• Onkologische Schwerpunktpraxis /ID# 147516 — Berlin, Germany
• Norton Cancer Institute /ID# 149788 — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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