A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor

• Status: Active, not recruiting
• Trial end date: 2022-09-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation OR those who have received prior treatment with a B-cell receptor inhibitor.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Receptors, Antigen, B-Cell; Venetoclax

Criteria

Inclusion Criteria:

• 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 AND/OR

• 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 reference range at Screening

Exclusion Criteria:

• 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