VENICE I
Brief summary
The purpose of this open-label, single-arm study is to evaluate the efficacy of an active drug monotherapy in approximately 250 participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received prior treatment with a B-cell receptor inhibitor. The starting dose of the active drug is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving the active drug for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 99 Years.
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 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
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