Phase 3
Completed N=210
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).
Source: ClinicalTrials.gov NCT02980731 ↗Enrolled (actual)
210
Serious AEs
50.5%
Results posted
Feb 2023
Primary outcomePrimary: 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) — 9.3 units on a scale — p==0.004
◆ Published Evidence
Emerging
14citations · ~4 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
9.3 | =0.004 sig |
| SECONDARY 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) |
3.9; 6.0; 7.6; 9.2; 9.4; 9.3 | — |
| SECONDARY 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) |
1.2; 3.0; 4.6; 5.2; 5.6; 6.1 | — |
| SECONDARY 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) |
2.6; 4.0; 7.1; 9.2; 9.8; 10.4 | — |
| SECONDARY 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) |
4.9; 4.7; 5.7; 3.6; 4.3; 5.7 | — |
| SECONDARY 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) |
2.3; 4.2; 4.3; 3.4; 3.8; 3.7 | — |
| SECONDARY 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) |
2.2; 5.5; 6.6; 7.2; 8.6; 9.9 | — |
| SECONDARY 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) |
-4.6; -7.7; -11.2; -10.9; -12.5; -12.9 | — |
| SECONDARY 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) |
-0.2; 0.4; -0.3; -1.5; -2.0; -0.6 | — |
| SECONDARY 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) |
-4.6; -2.9; -3.6; -4.1; -4.0; -4.6 | — |
| SECONDARY 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) |
-3.7; -5.5; -7.7; -8.5; -8.3; -8.5 | — |
| SECONDARY 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) |
-6.5; -7.9; -9.1; -9.0; -8.3; -11.6 | — |
| SECONDARY 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) |
-3.4; -6.2; -6.0; -8.8; -8.1; -7.8 | — |
| SECONDARY 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) |
1.7; 2.5; 1.4; 1.1; -0.8; -0.2 | — |
| SECONDARY 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) |
-0.7; 1.8; 2.3; 4.7; 4.6; 4.0 | — |
| SECONDARY 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) |
-6.4; -4.6; -6.0; -7.3; -7.8; -8.9 | — |
| SECONDARY 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) |
-6.3; -10.2; -13.9; -15.3; -16.3; -16.1 | — |
| SECONDARY 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) |
-2.6; -4.0; -4.8; -7.5; -7.8; -7.5 | — |
| SECONDARY 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) |
-10.7; -10.0; -12.4; -13.7; -13.9; -13.4 | — |
| SECONDARY 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) |
-3.5; -6.0; -4.6; -6.1; -8.9; -9.0 | — |
| SECONDARY 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) |
-4.0; -7.5; -8.5; -10.6; -13.7; -15.6 | — |
| SECONDARY 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) |
-17.2; -21.6; -25.5; -23.0; -24.4; -24.1 | — |
| SECONDARY Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score |
3.67; 6.00; 7.75; 7.78; 9.08; 10.34 | — |
| SECONDARY Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Index Score |
0.02; 0.02; 0.03; 0.03; 0.04; 0.04 | — |
| SECONDARY Complete Remission Rate (Complete Remission [CR] + Complete Remission With Incomplete Marrow Recovery [CRi]) |
18.6 | — |
| SECONDARY Overall Response Rate (ORR) |
76.7 | — |
| SECONDARY Duration of Overall Response (DOR) |
36.0 | — |
| SECONDARY Time to Progression (TTP) |
43.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
35.5 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
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
Data sourced from ClinicalTrials.gov (NCT02980731) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.