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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT02756611
• Date of registration: 26/04/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) VENICE I
• Scientific title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)
• Date of first enrolment: June 22, 2016
• Target sample size: 258
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02756611
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Venetoclax

Primary Outcome(s)

Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Secondary Outcome(s)

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) [Time Frame: Baseline and Weeks 48 and 108]

Overall Survival (OS) - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Progression-Free Survival (PFS) - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score [Time Frame: Baseline and Weeks 48 and 108]

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score [Time Frame: Baseline and Weeks 48 and 108]

Time to Progression (TTP) - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Overall Response Rate (ORR) - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) [Time Frame: Baseline and Weeks 48 and 108]

Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Duration of Overall Response (DOR) - Primary Analysis [Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.]

Secondary ID(s)

M15-550

2015-003667-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02756611