A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
VENICE II
Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)
2 other identifiers
interventional
210
10 countries
33
Brief Summary
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) with or without the 17p deletion or TP53 mutation, including participants with an unknown status, as well as R/R CLL participants who had been previously treated with B-cell receptor inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may have continued receiving venetoclax for up to 2 years. After the treatment period, participants may have continued on into a 2-year follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2016
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedStudy Start
First participant enrolled
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2021
CompletedResults Posted
Study results publicly available
February 22, 2023
CompletedFebruary 22, 2023
January 1, 2023
5 years
November 30, 2016
December 21, 2022
January 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to Week 48 in Global Health Status/Quality of Life (GHS/QoL) Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change.
Baseline, Week 48
Secondary Outcomes (29)
Mean Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, Final visit (at study drug discontinuation and/or upon discontinuation from the study, up to Week 108)
Mean Change From Baseline in Physical Functioning Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, Final visit (at study drug discontinuation and/or upon discontinuation from the study, up to Week 108)
Mean Change From Baseline in Role Functioning Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, Final visit (at study drug discontinuation and/or upon discontinuation from the study, up to Week 108)
Mean Change From Baseline in Emotional Functioning Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, Final visit (at study drug discontinuation and/or upon discontinuation from the study, up to Week 108)
Mean Change From Baseline in Cognitive Functioning Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, Final visit (at study drug discontinuation and/or upon discontinuation from the study, up to Week 108)
- +24 more secondary outcomes
Study Arms (1)
Venetoclax
EXPERIMENTALVenetoclax was administered orally once daily (QD) for a planned duration of up to 2 years or until disease progression; median time on treatment was 127 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Interventions
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
- Participant has relapsed/refractory disease (received at least one prior therapy)
- Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines and:
- has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines
- has clinically measurable disease (lymphocytosis \> 5 × 10\^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
- with or without 17p deletion or TP53 mutation
- may have been previously treated with a prior B-cell receptor inhibitor therapy
- Adequate bone marrow function
You may not qualify if:
- Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL)
- 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
- Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids
- Prior allogeneic stem cell transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (33)
Hospital Italiano La Plata /ID# 150812
La Plata, Buenos Aires, 1902, Argentina
Fundaleu /Id# 150811
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1114, Argentina
Cemic /Id# 150810
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1431, Argentina
Sanatorio Allende /ID# 150813
Córdoba, 5000, Argentina
St George Hospital /ID# 154212
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital /ID# 154950
Liverpool, New South Wales, 2170, Australia
Gold coast University Hospital /ID# 150833
Southport, Queensland, 4215, Australia
Peter MacCallum Cancer Ctr /ID# 154948
Melbourne, Victoria, 3000, Australia
Perth Blood Institute Ltd /ID# 154949
Nedlands, Western Australia, 6009, Australia
UMHAT Alexandrovska EAD /ID# 162987
Sofiya, Sofia, 1431, Bulgaria
UMHAT Sveti Georgi /ID# 161594
Plovdiv, 4002, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 163280
Sofia, 1431, Bulgaria
SHAT Hematologic Diseases /ID# 161592
Sofia, 1756, Bulgaria
Prince of Wales Hospital /ID# 150837
Hong Kong, 999077, Hong Kong
Queen Mary Hospital /ID# 150836
Hong Kong, 999077, Hong Kong
Semmelweis Egyetem /ID# 150792
Budapest, 1085, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152842
Budapest, 1097, Hungary
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 163641
Morelia, Michoacán, 58260, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 150821
Monterrey, Nuevo León, 64460, Mexico
Middlemore Clinical Trials /ID# 161526
Papatoetoe, Auckland, 2025, New Zealand
North Shore Hospital /ID# 157626
Takapuna, Auckland, 0622, New Zealand
Wellington Regional Hospital /ID# 157627
Newtown, Wellington Region, 6021, New Zealand
Instytut Hematologii i Transfuzjologii /ID# 150878
Warsaw, Masovian Voivodeship, 02-776, Poland
Szpitale Pomorskie Sp. z o.o /ID# 164097
Gdynia, Pomeranian Voivodeship, 81-519, Poland
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 150877
Chorzów, Silesian Voivodeship, 41-500, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 150880
Lodz, Łódź Voivodeship, 93-513, Poland
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 166610
Moscow, Moscow, 115478, Russia
Moscow State budget healthcare /ID# 154806
Moscow, Moscow, 125284, Russia
Regional Oncological Dispensary /ID# 154202
Penza, Penza Oblast, 440071, Russia
Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 154213
Moscow, 125167, Russia
China Medical University Hospital /ID# 150839
Taichung, 40447, Taiwan
National Taiwan University Hospital /ID# 150838
Taipei, 100, Taiwan
Taipei Veterans General Hosp /ID# 153803
Taipei, 11217, Taiwan
Related Publications (1)
Cochrane T, Enrico A, Gomez-Almaguer D, Hadjiev E, Lech-Maranda E, Masszi T, Nikitin E, Robak T, Weinkove R, Wu SJ, Sail KR, Pesko J, Pai M, Komlosi V, Anderson MA. Impact of venetoclax monotherapy on the quality of life of patients with relapsed or refractory chronic lymphocytic leukemia: results from the phase 3b VENICE II trial. Leuk Lymphoma. 2022 Feb;63(2):304-314. doi: 10.1080/10428194.2021.1986217. Epub 2021 Oct 11.
PMID: 34632935DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2016
First Posted
December 2, 2016
Study Start
December 13, 2016
Primary Completion
December 29, 2021
Study Completion
December 29, 2021
Last Updated
February 22, 2023
Results First Posted
February 22, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.