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).
CompletedPhase 3Results postedLast updated 22 February 2023
What this trial tests
Phase 3 trial testing Venetoclax in Chronic Lymphocytic Leukemia (CLL) in 210 participants. Completed in 29 December 2021.
Adults 18 to 99, any sex, with Chronic Lymphocytic Leukemia (CLL). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· Baseline, Week 48
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.
Group
Value
95% CI
Venetoclax
9.3
± 20.11
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
3.9
± 17.65
Week 8
Group
Value
95% CI
Venetoclax
6.0
± 20.67
Week 12
Group
Value
95% CI
Venetoclax
7.6
± 20.13
Week 24
Group
Value
95% CI
Venetoclax
9.2
± 20.29
Week 36
Group
Value
95% CI
Venetoclax
9.4
± 19.45
Week 48
Group
Value
95% CI
Venetoclax
9.3
± 20.11
Week 60
Group
Value
95% CI
Venetoclax
10.3
± 21.83
Week 72
Group
Value
95% CI
Venetoclax
10.2
± 23.87
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
1.2
± 12.86
Week 8
Group
Value
95% CI
Venetoclax
3.0
± 16.16
Week 12
Group
Value
95% CI
Venetoclax
4.6
± 15.89
Week 24
Group
Value
95% CI
Venetoclax
5.2
± 16.90
Week 36
Group
Value
95% CI
Venetoclax
5.6
± 15.59
Week 48
Group
Value
95% CI
Venetoclax
6.1
± 16.30
Week 60
Group
Value
95% CI
Venetoclax
6.0
± 17.73
Week 72
Group
Value
95% CI
Venetoclax
5.7
± 18.47
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
2.6
± 22.75
Week 8
Group
Value
95% CI
Venetoclax
4.0
± 28.31
Week 12
Group
Value
95% CI
Venetoclax
7.1
± 28.60
Week 24
Group
Value
95% CI
Venetoclax
9.2
± 26.85
Week 36
Group
Value
95% CI
Venetoclax
9.8
± 26.70
Week 48
Group
Value
95% CI
Venetoclax
10.4
± 26.10
Week 60
Group
Value
95% CI
Venetoclax
8.4
± 27.63
Week 72
Group
Value
95% CI
Venetoclax
11.6
± 31.01
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
4.9
± 16.30
Week 8
Group
Value
95% CI
Venetoclax
4.7
± 16.96
Week 12
Group
Value
95% CI
Venetoclax
5.7
± 17.11
Week 24
Group
Value
95% CI
Venetoclax
3.6
± 17.62
Week 36
Group
Value
95% CI
Venetoclax
4.3
± 17.08
Week 48
Group
Value
95% CI
Venetoclax
5.7
± 17.64
Week 60
Group
Value
95% CI
Venetoclax
5.2
± 18.79
Week 72
Group
Value
95% CI
Venetoclax
5.1
± 18.54
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
2.3
± 15.61
Week 8
Group
Value
95% CI
Venetoclax
4.2
± 18.93
Week 12
Group
Value
95% CI
Venetoclax
4.3
± 18.29
Week 24
Group
Value
95% CI
Venetoclax
3.4
± 18.42
Week 36
Group
Value
95% CI
Venetoclax
3.8
± 18.54
Week 48
Group
Value
95% CI
Venetoclax
3.7
± 17.15
Week 60
Group
Value
95% CI
Venetoclax
4.1
± 20.01
Week 72
Group
Value
95% CI
Venetoclax
4.7
± 17.65
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
2.2
± 19.14
Week 8
Group
Value
95% CI
Venetoclax
5.5
± 22.13
Week 12
Group
Value
95% CI
Venetoclax
6.6
± 22.26
Week 24
Group
Value
95% CI
Venetoclax
7.2
± 24.79
Week 36
Group
Value
95% CI
Venetoclax
8.6
± 21.63
Week 48
Group
Value
95% CI
Venetoclax
9.9
± 22.80
Week 60
Group
Value
95% CI
Venetoclax
9.2
± 25.78
Week 72
Group
Value
95% CI
Venetoclax
9.7
± 27.41
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
-4.6
± 18.63
Week 8
Group
Value
95% CI
Venetoclax
-7.7
± 22.70
Week 12
Group
Value
95% CI
Venetoclax
-11.2
± 24.66
Week 24
Group
Value
95% CI
Venetoclax
-10.9
± 20.70
Week 36
Group
Value
95% CI
Venetoclax
-12.5
± 23.21
Week 48
Group
Value
95% CI
Venetoclax
-12.9
± 21.40
Week 60
Group
Value
95% CI
Venetoclax
-13.0
± 22.79
Week 72
Group
Value
95% CI
Venetoclax
-13.8
± 25.90
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
-0.2
± 18.02
Week 8
Group
Value
95% CI
Venetoclax
0.4
± 17.19
Week 12
Group
Value
95% CI
Venetoclax
-0.3
± 18.50
Week 24
Group
Value
95% CI
Venetoclax
-1.5
± 17.24
Week 36
Group
Value
95% CI
Venetoclax
-2.0
± 16.19
Week 48
Group
Value
95% CI
Venetoclax
-0.6
± 19.45
Week 60
Group
Value
95% CI
Venetoclax
-0.3
± 15.42
Week 72
Group
Value
95% CI
Venetoclax
0.3
± 17.40
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
-4.6
± 21.05
Week 8
Group
Value
95% CI
Venetoclax
-2.9
± 21.31
Week 12
Group
Value
95% CI
Venetoclax
-3.6
± 22.56
Week 24
Group
Value
95% CI
Venetoclax
-4.1
± 22.08
Week 36
Group
Value
95% CI
Venetoclax
-4.0
± 22.43
Week 48
Group
Value
95% CI
Venetoclax
-4.6
± 20.29
Week 60
Group
Value
95% CI
Venetoclax
-5.2
± 23.46
Week 72
Group
Value
95% CI
Venetoclax
-4.7
± 23.30
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
-3.7
± 23.33
Week 8
Group
Value
95% CI
Venetoclax
-5.5
± 26.62
Week 12
Group
Value
95% CI
Venetoclax
-7.7
± 29.08
Week 24
Group
Value
95% CI
Venetoclax
-8.5
± 26.56
Week 36
Group
Value
95% CI
Venetoclax
-8.3
± 28.43
Week 48
Group
Value
95% CI
Venetoclax
-8.5
± 27.19
Week 60
Group
Value
95% CI
Venetoclax
-8.5
± 26.08
Week 72
Group
Value
95% CI
Venetoclax
-9.2
± 31.30
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)Secondary· 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)
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.
Week 4
Group
Value
95% CI
Venetoclax
-6.5
± 25.78
Week 8
Group
Value
95% CI
Venetoclax
-7.9
± 30.39
Week 12
Group
Value
95% CI
Venetoclax
-9.1
± 29.27
Week 24
Group
Value
95% CI
Venetoclax
-9.0
± 27.19
Week 36
Group
Value
95% CI
Venetoclax
-8.3
± 30.68
Week 48
Group
Value
95% CI
Venetoclax
-11.6
± 25.77
Week 60
Group
Value
95% CI
Venetoclax
-10.2
± 28.94
Week 72
Group
Value
95% CI
Venetoclax
-7.8
± 29.40
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from enrollment to end of study; median time on follow-up was 184 weeks. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 123 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Venetoclax
Serious: 106/210 (50%)
Deaths: 65/210
Serious adverse events (128 terms)
Reaction
System
Venetoclax
PNEUMONIA
Infections and infestations
—
PYREXIA
General disorders
—
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
—
THROMBOCYTOPENIA
Blood and lymphatic system disorders
—
ANAEMIA
Blood and lymphatic system disorders
—
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
—
AUTOIMMUNE HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
—
INFLUENZA
Infections and infestations
—
DIARRHOEA
Gastrointestinal disorders
—
COVID-19 PNEUMONIA
Infections and infestations
—
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
—
ARTHRALGIA
Musculoskeletal and connective tissue disorders
—
IMMUNE THROMBOCYTOPENIA
Blood and lymphatic system disorders
—
NEUTROPENIA
Blood and lymphatic system disorders
—
CHOLECYSTITIS
Hepatobiliary disorders
—
CELLULITIS
Infections and infestations
—
HAEMOPHILUS INFECTION
Infections and infestations
—
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
—
PNEUMONIA PSEUDOMONAL
Infections and infestations
—
PNEUMONIA VIRAL
Infections and infestations
—
SEPSIS
Infections and infestations
—
STREPTOCOCCAL INFECTION
Infections and infestations
—
FEMORAL NECK FRACTURE
Injury, poisoning and procedural complications
—
HIP FRACTURE
Injury, poisoning and procedural complications
—
HYPERKALAEMIA
Metabolism and nutrition disorders
—
Other adverse events (25 terms — click to expand)
Reaction
System
Venetoclax
NEUTROPENIA
Blood and lymphatic system disorders
—
DIARRHOEA
Gastrointestinal disorders
—
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
—
THROMBOCYTOPENIA
Blood and lymphatic system disorders
—
NAUSEA
Gastrointestinal disorders
—
ANAEMIA
Blood and lymphatic system disorders
—
ARTHRALGIA
Musculoskeletal and connective tissue disorders
—
COUGH
Respiratory, thoracic and mediastinal disorders
—
PYREXIA
General disorders
—
HYPERTENSION
Vascular disorders
—
CONSTIPATION
Gastrointestinal disorders
—
BRONCHITIS
Infections and infestations
—
HEADACHE
Nervous system disorders
—
RASH
Skin and subcutaneous tissue disorders
—
VOMITING
Gastrointestinal disorders
—
FATIGUE
General disorders
—
BACK PAIN
Musculoskeletal and connective tissue disorders
—
HYPOKALAEMIA
Metabolism and nutrition disorders
—
INSOMNIA
Psychiatric disorders
—
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
—
HYPOCALCAEMIA
Metabolism and nutrition disorders
—
OEDEMA PERIPHERAL
General disorders
—
PNEUMONIA
Infections and infestations
—
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
—
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients
· Phase 2, PHASE3
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological
· Phase 1, PHASE2
· not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients
· Phase 1
· not yet recruiting
NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
· Phase 1
· not yet recruiting
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· recruiting
NCT05724121 — Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 22 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02980731.