Adults 18 to 99, any sex, with Chronic Lymphocytic Leukemia. 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.
Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary AnalysisPrimary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria.
CR required all of the following:
* Peripheral blood lymphocytes \< 4000/μL
* Absence of lymphadenopathy by physical examination and computed tomography scan
* No hepatomegaly or splenomegaly by physical examination
* Absence of disease or con
Group
Value
95% CI
Venetoclax
35.1
28.3 – 42.3
Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria.
CR required all of the following:
* Peripheral blood lymphocytes \< 4000/μL
* Absence of lymphadenopathy by physical examination and computed tomography scan
* No hepatomegaly or splenomegaly by physical examination
* Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in la
Group
Value
95% CI
Venetoclax
25.4
15.5 – 37.5
Overall Response Rate (ORR) - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator.
CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically.
For PR at least 2 of the following must be met:
* 50% decrease in peripheral blood lymphocyte count from the Baseline value;
* 50% reduction in lymphadenopathy;
* 50% reduction in the size of the liver and/or spleen (if abno
Group
Value
95% CI
Venetoclax
79.8
74.4 – 84.6
Duration of Overall Response (DOR) - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date.
Group
Value
95% CI
Venetoclax
25.2
23.0 – 25.2
Time to Progression (TTP) - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology.
Group
Value
95% CI
Venetoclax
30.5
29.6 – 30.5
Progression-Free Survival (PFS) - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology.
Group
Value
95% CI
Venetoclax
30.5
28.6 – 30.5
Overall Survival (OS) - Primary AnalysisSecondary· From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.
Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.
Group
Value
95% CI
Venetoclax
NA
NA – NA
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu)Secondary· Baseline and Weeks 48 and 108
The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess health-related quality of life (HRQoL) and leukemia-specific symptoms using a core set of questions (Functional Assessment of Cancer Therapy-General; FACT-G), and a cancer site-specific leukemia subscale. Questions are scored on a scale from 0 (not at all) to 4 (very much).
FACT-G consists of 27 general items divided into 4 primary HRQoL domains: Physical Well-being (PWB; 7 items; score range 0-28), Social/Family Well-being (SWB; 7 items; score range 0-28), Emotional Well-being (EWB; 6 items; score range 0-24), Func
Physical well-being - Week 48
Group
Value
95% CI
Venetoclax
1.2
± 4.07
Physical well-being - Week 108
Group
Value
95% CI
Venetoclax
0.9
± 4.20
Social/family well-being - Week 48
Group
Value
95% CI
Venetoclax
0.2
± 5.14
Social/family well-being - Week 108
Group
Value
95% CI
Venetoclax
-0.4
± 4.86
Emotional well-being - Week 48
Group
Value
95% CI
Venetoclax
2.1
± 3.52
Emotional well-being - Week 108
Group
Value
95% CI
Venetoclax
1.7
± 3.94
Functional well-being - Week 48
Group
Value
95% CI
Venetoclax
1.8
± 5.63
Functional well-being - Week 108
Group
Value
95% CI
Venetoclax
1.4
± 5.67
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)Secondary· Baseline and Weeks 48 and 108
The FACIT-Fatigue questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-Fatigue includes 13 items answered on a 5-point rating scale based on a 7-day recall period. Scores range from 0 to 52, with lower scores reflecting greater fatigue.
Week 48
Group
Value
95% CI
Venetoclax
4.9
± 9.43
Week 108
Group
Value
95% CI
Venetoclax
3.3
± 9.96
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index ScoreSecondary· Baseline and Weeks 48 and 108
The EQ-5D-5L is a generic measure of health status consisting of two parts: a descriptive system consisting of 5 items and a visual analog scale (VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participant is asked to rate each dimension on 5 levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems).
The scores for the 5 dimensions are used to compute a single health utility index score representing the general health status of the individual
Week 48
Group
Value
95% CI
Venetoclax
0.0
± 0.14
Week 108
Group
Value
95% CI
Venetoclax
0.0
± 0.15
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale ScoreSecondary· Baseline and Weeks 48 and 108
The EQ-5D-5L is a generic measure of health status consisting of two parts, a descriptive system consisting of 5 items and a visual analog scale (VAS).
The VAS assesses the participant's self-rated overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Week 48
Group
Value
95% CI
Venetoclax
8.5
± 14.43
Week 108
Group
Value
95% CI
Venetoclax
7.1
± 14.61
Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Final AnalysisSecondary· From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.
Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria.
CR required all of the following:
* Peripheral blood lymphocytes \< 4000/μL
* Absence of lymphadenopathy by physical examination and computed tomography scan
* No hepatomegaly or splenomegaly by physical examination
* Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in la
Group
Value
95% CI
Venetoclax
34.6
27.8 – 41.8
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Venetoclax
Serious: 136/258 (53%)
Deaths: 70/258
Serious adverse events (170 terms)
Reaction
System
Venetoclax
PNEUMONIA
Infections and infestations
—
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
—
PYREXIA
General disorders
—
ANAEMIA
Blood and lymphatic system disorders
—
DIARRHOEA
Gastrointestinal disorders
—
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
—
NEUTROPENIA
Blood and lymphatic system disorders
—
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
—
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
—
HYPERKALAEMIA
Metabolism and nutrition disorders
—
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· 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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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: 10 April 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/NCT02756611.