VENICE I

A Study to Evaluate the Efficacy of an Active Drug 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.

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

Status:
Completed
Conditions:
Chronic Lymphocytic Leukemia
Enrollment:
258 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-550
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

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 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

All the cities where the clinical studies are located

Vancouver - V5Z 1L3
Halifax - B3H 1V7
Hamilton - L8V 1C3
Toronto - M4N 3M5
Quebec City - G1R 2J6
Quebec City - G1R 2J6

British Columbia

Nova Scotia

Quebec