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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02980731




Registration number
NCT02980731
Ethics application status
Date submitted
30/11/2016
Date registered
2/12/2016
Date last updated
5/01/2021

Titles & IDs
Public title
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).
Scientific title
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)
Secondary ID [1] 0 0
2016-001097-15
Secondary ID [2] 0 0
M15-889
Universal Trial Number (UTN)
Trial acronym
VENICE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia (CLL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax

Experimental: Venetoclax - Venetoclax will be administered orally 20 mg once daily (QD) beginning with a dose-titration phase, and then escalated up to 400 mg QD.


Treatment: Drugs: Venetoclax
Tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change 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 subject 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 on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
Timepoint [1] 0 0
From Screening (Baseline) up to Week 48
Secondary outcome [1] 0 0
Complete Remission rate (complete remission [CR] + complete remission with incomplete marrow recovery [CRi]) - Complete remission rate (CR + CRi) defined as the proportion of subjects achieving a CR or CRi as their best response (per the investigator assessment) based on IWCLL NCI -WG criteria.
Timepoint [1] 0 0
When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier.
Secondary outcome [2] 0 0
Duration of Overall Response (DOR) - DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the earliest recurrence or progressive disease.
Timepoint [2] 0 0
Measured up to 2 years after the last participant has enrolled in the study.
Secondary outcome [3] 0 0
Duration of Progression-Free Survival (PFS) - PFS defined as the number of days from the date of first dose of venetoclax to the date of disease progression or death, whichever occurs first.
Timepoint [3] 0 0
Measured up to 2 years after the last participant has enrolled into the study.
Secondary outcome [4] 0 0
Time to Progression (TTP) - TPP defined as the number of days from the date of first dose of venetoclax to the date of disease progression.
Timepoint [4] 0 0
Measured up to 2 years after the last participant has enrolled in the study.
Secondary outcome [5] 0 0
EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) - The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health.
Timepoint [5] 0 0
From Screening (Baseline; Day 0) up to Week 48
Secondary outcome [6] 0 0
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16), - EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of HRQoL important in CLL. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." A negative change in score from baseline represents an improvement in symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Timepoint [6] 0 0
From Screening (Baseline; Day 0) up to Week 48
Secondary outcome [7] 0 0
Overall Survival (OS) - OS defined as number of days from the date of first dose of venetoclax to the date of death for all dosed participants.
Timepoint [7] 0 0
Measured up to 2 years after the last participant has enrolled into the study.
Secondary outcome [8] 0 0
Change in the remaining subscales/items from the EORTC QLQ-C30. - The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Subjects rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Timepoint [8] 0 0
From Screening (Baseline; Day 0) up to Week 48
Secondary outcome [9] 0 0
Overall Response Rate (ORR) - ORR assessed as the proportion of participants with an overall response (CR + CRi + Nodular Partial Remission [nPR] + Partial Remission [PR]) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group Guidelines (IWCLL NCI-WG) criteria.
Timepoint [9] 0 0
Measured up to 2 years after the last participant has enrolled in the study.

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
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.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital /ID# 154212 - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital /ID# 154950 - Liverpool
Recruitment hospital [3] 0 0
Gold Coast University Hospital /ID# 150833 - Southport
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Ctr /ID# 154948 - Melbourne
Recruitment hospital [5] 0 0
Perth Blood Institute Ltd /ID# 154949 - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Plovdiv
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Mexico
State/province [8] 0 0
Michoacan
Country [9] 0 0
Mexico
State/province [9] 0 0
Nuevo Leon
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Newtown Wellington
Country [12] 0 0
Poland
State/province [12] 0 0
Lodzkie
Country [13] 0 0
Poland
State/province [13] 0 0
Chorzow
Country [14] 0 0
Poland
State/province [14] 0 0
Gdynia
Country [15] 0 0
Poland
State/province [15] 0 0
Warsaw
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moskva
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Moscow
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Penza
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taichung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this open-label, single-arm study is 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 subjects with an unknown status,
as well as R/R CLL subjects who have been previously treated with B-cell receptor inhibitor
(BCRi) therapy. The starting dose of venetoclax is 20 mg once daily. The dose must be
gradually increased over a period of 5 weeks up to the daily dose of 400mg. Participants may
continue receiving venetoclax for up to 2 years. After the treatment period, participants may
continue on into a 2-year follow-up period.
Trial website
https://clinicaltrials.gov/show/NCT02980731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications