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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)

Primary Purpose

Chronic Lymphocytic Leukemia (CLL)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Relapsed CLL, Refractory CLL, 17p deletion, TP53 gene, B-Cell receptor inhibitor (BCRi), European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Overall response rate (ORR), Duration of overall response (DOR), Complete remission rate (CR + CRi), Progression-free survival (PFS), Overall survival (OS)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Hospital Italiano La Plata /ID# 150812
  • Fundaleu /Id# 150811
  • Cemic /Id# 150810
  • Sanatorio Allende /ID# 150813
  • St George Hospital /ID# 154212
  • Liverpool Hospital /ID# 154950
  • Gold coast University Hospital /ID# 150833
  • Peter MacCallum Cancer Ctr /ID# 154948
  • Perth Blood Institute Ltd /ID# 154949
  • UMHAT Alexandrovska EAD /ID# 162987
  • UMHAT Sveti Georgi /ID# 161594
  • UMHAT Sveti Ivan Rilski /ID# 163280
  • SHAT Hematologic Diseases /ID# 161592
  • Prince of Wales Hospital /ID# 150837
  • Queen Mary Hospital /ID# 150836
  • Semmelweis Egyetem /ID# 150792
  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152842
  • Centro de Investigacion Clínica Chapultepec SA de CV /ID# 163641
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 150821
  • Middlemore Clinical Trials /ID# 161526
  • North Shore Hospital /ID# 157626
  • Wellington Regional Hospital /ID# 157627
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 150880
  • Instytut Hematologii i Transfuzjologii /ID# 150878
  • Szpitale Pomorskie Sp. z o.o /ID# 164097
  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 150877
  • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 166610
  • Moscow State budget healthcare /ID# 154806
  • Regional Oncological Dispensary /ID# 154202
  • Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 154213
  • China Medical University Hospital /ID# 150839
  • National Taiwan University Hospital /ID# 150838
  • Taipei Veterans General Hosp /ID# 153803

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetoclax

Arm Description

Venetoclax 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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)
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a physical functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the physical functioning 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.
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)
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a role functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the role functioning 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.
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)
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including an emotional functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the emotional functioning 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.
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)
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a cognitive functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the cognitive functioning 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.
Mean Change From Baseline in Social Functioning 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 social functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the social functioning 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.
Mean Change From Baseline in Fatigue 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 fatigue scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the fatigue scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Nausea and Vomiting 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 nausea and vomiting scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the nausea and vomiting scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Pain 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 pain scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the pain scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Dyspnea 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 dyspnea scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the dyspnea scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Insomnia 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 an insomnia scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the insomnia scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Appetite Loss 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 an appetite loss scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the appetite loss scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Constipation 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 constipation scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the constipation scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Diarrhea 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 diarrhea scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the diarrhea scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Financial Difficulties 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 financial difficulties scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the financial difficulties scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Fatigue Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the fatigue scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Treatment Side Effects Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the treatment side effects scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Disease Effects Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the disease effects scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Infection Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the infection scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Social Problems Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the social problems scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in Future Health Subscale of the 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 health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the future health scale indicates a lower level of functioning, and negative 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.
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score
The EQ-5D 5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). Participants rated their health on a vertical visual analogue scale, where the endpoints were labelled 100, "The best health you can imagine" and 0, "The worst health you can imagine". Positive values indicate improvement from baseline.
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Index Score
The EQ-5D 5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). 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, with '0' defined as a health state equivalent to being dead and '1' is full health. The higher the score the better the health status. Positive values indicate improvement from baseline.
Complete Remission Rate (Complete Remission [CR] + Complete Remission With Incomplete Marrow Recovery [CRi])
Complete remission rate (CR + CRi) is defined as the percentage of participants achieving a CR or CRi as their best response (per the investigator assessment) based on 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria as assessed by investigator using the best response at any time during the study.
Duration of Overall Response (DOR)
DoR is defined as the number of days from the date of first response (complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria to the earliest date of progressive disease (PD) or death. DOR was analyzed by Kaplan-Meier (K-M) methodology.
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose of venetoclax to the date of earliest disease progression (PD). TTP was analyzed by Kaplan-Meier (K-M) methodology.
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of first dose of venetoclax to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.
Overall Survival (OS)
OS is defined as the number of days from the date of first dose of venetoclax to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. OS was estimated using Kaplan-Meier methodology.

Full Information

First Posted
November 30, 2016
Last Updated
January 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02980731
Brief 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).
Acronym
VENICE II
Official 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) (VENICE II)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
December 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)
Keywords
Relapsed CLL, Refractory CLL, 17p deletion, TP53 gene, B-Cell receptor inhibitor (BCRi), European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Overall response rate (ORR), Duration of overall response (DOR), Complete remission rate (CR + CRi), Progression-free survival (PFS), Overall survival (OS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax
Arm Type
Experimental
Arm Description
Venetoclax 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.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, VENCLEXTA, VENCLYXTO
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline, Week 48
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
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)
Title
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)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a physical functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the physical functioning 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.
Time Frame
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)
Title
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)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a role functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the role functioning 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.
Time Frame
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)
Title
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)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including an emotional functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the emotional functioning 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.
Time Frame
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)
Title
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)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a cognitive functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the cognitive functioning 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.
Time Frame
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)
Title
Mean Change From Baseline in Social Functioning Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a social functioning scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the social functioning 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.
Time Frame
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)
Title
Mean Change From Baseline in Fatigue Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a fatigue scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the fatigue scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Nausea and Vomiting Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a nausea and vomiting scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the nausea and vomiting scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Pain Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a pain scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the pain scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Dyspnea Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a dyspnea scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the dyspnea scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Insomnia Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including an insomnia scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the insomnia scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Appetite Loss Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including an appetite loss scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the appetite loss scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Constipation Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a constipation scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the constipation scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Diarrhea Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a diarrhea scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the diarrhea scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Financial Difficulties Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Description
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a financial difficulties scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the financial difficulties scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Fatigue Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the fatigue scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Treatment Side Effects Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the treatment side effects scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Disease Effects Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the disease effects scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Infection Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the infection scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Social Problems Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the social problems scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in Future Health Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16)
Description
EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life important in CLL. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the future health scale indicates a lower level of functioning, and negative 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.
Time Frame
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)
Title
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score
Description
The EQ-5D 5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). Participants rated their health on a vertical visual analogue scale, where the endpoints were labelled 100, "The best health you can imagine" and 0, "The worst health you can imagine". Positive values indicate improvement from baseline.
Time Frame
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)
Title
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Index Score
Description
The EQ-5D 5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). 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, with '0' defined as a health state equivalent to being dead and '1' is full health. The higher the score the better the health status. Positive values indicate improvement from baseline.
Time Frame
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)
Title
Complete Remission Rate (Complete Remission [CR] + Complete Remission With Incomplete Marrow Recovery [CRi])
Description
Complete remission rate (CR + CRi) is defined as the percentage of participants achieving a CR or CRi as their best response (per the investigator assessment) based on 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria as assessed by investigator using the best response at any time during the study.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks
Title
Duration of Overall Response (DOR)
Description
DoR is defined as the number of days from the date of first response (complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines criteria to the earliest date of progressive disease (PD) or death. DOR was analyzed by Kaplan-Meier (K-M) methodology.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks
Title
Time to Progression (TTP)
Description
TTP is defined as the number of days from the date of first dose of venetoclax to the date of earliest disease progression (PD). TTP was analyzed by Kaplan-Meier (K-M) methodology.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the number of days from the date of first dose of venetoclax to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks
Title
Overall Survival (OS)
Description
OS is defined as the number of days from the date of first dose of venetoclax to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. OS was estimated using Kaplan-Meier methodology.
Time Frame
From the first dose of study drug until the last participant completed the Week 48 assessments; median time on follow-up was 184 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Italiano La Plata /ID# 150812
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1902
Country
Argentina
Facility Name
Fundaleu /Id# 150811
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1114
Country
Argentina
Facility Name
Cemic /Id# 150810
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Sanatorio Allende /ID# 150813
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
St George Hospital /ID# 154212
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital /ID# 154950
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Gold coast University Hospital /ID# 150833
City
SouthPort
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Peter MacCallum Cancer Ctr /ID# 154948
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Perth Blood Institute Ltd /ID# 154949
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UMHAT Alexandrovska EAD /ID# 162987
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Sveti Georgi /ID# 161594
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 163280
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
SHAT Hematologic Diseases /ID# 161592
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Prince of Wales Hospital /ID# 150837
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Queen Mary Hospital /ID# 150836
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Semmelweis Egyetem /ID# 150792
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152842
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 163641
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 150821
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Middlemore Clinical Trials /ID# 161526
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
North Shore Hospital /ID# 157626
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 157627
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 150880
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii /ID# 150878
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o /ID# 164097
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 150877
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 166610
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow State budget healthcare /ID# 154806
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Regional Oncological Dispensary /ID# 154202
City
Penza
State/Province
Penzenskaya Oblast
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 154213
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
China Medical University Hospital /ID# 150839
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 150838
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 153803
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
34632935
Citation
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.
Results Reference
derived

Learn more about this trial

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).

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