Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL
Active, enrolledPhase 2Results postedLast updated 13 February 2026
What this trial tests
Phase 2 trial testing Venetoclax in Chronic Lymphocytic Leukemia (CLL) in 72 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, 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.
Rate of Bone Marrow (BM) Minimal Residual Disease (MRD) Negative Complete Response (CR) After 15 CyclesPrimary· BM biopsy evaluated at baseline, cycle 4, 8, 16 on day 1. Relative to this endpoint is after 15 cycles
The rate of BM MRD was defined as the proportion of participants achieving CR and negative MRD based on 2018 IW-CLL criteria.
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.378
0.224 – 0.552
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.457
0.283 – 0.638
Rate of Partial Response (PRR) After 15 CyclesSecondary· BM biopsy evaluated at baseline, cycle 4, 8, 16 on day 1. Relative to this endpoint is after 15 cycles
The PRR was defined as the proportion of participants achieving PR based on 2018 IW-CLL criteria.
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.54
0.37 – 0.698
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.4
0.236 – 0.582
Rate of Complete Response ( Including With Incomplete Count Recovery (CRi))Secondary· BM biopsy evaluated at baseline, cycle 4, 8, 16, 25 on day 1.
The CR+CRi rate was defined as the proportion of participants achieving CR+CRi based on 2018 IW-CLL criteria.
After cycle 8
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.24
0.12 – 0.41
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.2
0.08 – 0.37
After cycle 16
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.432
0.267 – 0.609
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.51
0.336 – 0.689
After cycle 25
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.46
0.29 – 0.63
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.62
0.44 – 0.79
Median Progression-Free Survival (PFS)Secondary· Disease evaluated at baseline, cycle 4, 8, 16 on day 1, and every 3 months thereafter. Median follow-up for all patients was 55.23 months.
Progression-free survival based on the Kaplan-Meier method is defined as the duration between starting study therapy and documented disease progression (PD) or death, censored at time of last disease assessment.
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
NA
NA – NA
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
49.38
49.38 – NA
Median Overall Survival (OS)Secondary· Up to 2 years
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
NA
NA – NA
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
NA
NA – NA
Rate of Peripheral Blood (PB) MRDSecondary· PB MRD evaluated on cycle 4, 8, 13, 16, 19, 22, 25, and every 3 cycles thereafter on day 1.
The rate of PB MRD was defined as the proportion of participants achieving negative MRD based on 2018 IW-CLL criteria. PB MRD evaluate by flow cytometry.
after 8 cycles
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.68
0.5 – 0.82
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.69
0.51 – 0.83
after 16 cycles
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.86
0.71 – 0.95
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.8
0.63 – 0.92
after 25 cycles
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
0.89
0.75 – 0.97
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
0.69
0.5 – 0.84
Median Time to BM MRD-positive Disease RecurrenceSecondary· Disease evaluated at baseline, cycle 4, 8, 16 on day 1.
Median Time to BM MRD-positive Disease Recurrence based on the Kaplan-Meier method, is defined as the duration from the date of achieving MRD-negative status in the bone marrow to the date of first documented MRD-positive recurrence in the bone marrow, or death, whichever occurs first.
Group
Value
95% CI
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
NA
NA – NA
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: AE collection thought entire study, on cycle 1 day 1, cycle 2 day 1, 2, 8, 15, 22, cycle 3 day 1 and 15, cycle 4 day 1, 2, 3, 8, 9, 15, 16, 22, 23, cycle 5 day 1 and 15, then day 1 on each cycle. Median duration of treatment is 25.56 months with range (0.56, 52.2)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With Non-high-risk CLL Disease
Serious: 10/37 (27%)
Deaths: 0/37
Acalabrutinib/Venetoclax/Obinutuzumab (AVO) With High-risk CLL Disease
Serious: 9/35 (26%)
Deaths: 3/35
Serious adverse events (15 terms)
Reaction
System
Acalabrutinib/Venetoclax/O…
Acalabrutinib/Venetoclax/O…
Neutrophil count decreased
Investigations
—
—
Lung infection
Infections and infestations
—
—
Colitis
Gastrointestinal disorders
—
—
Non-cardiac chest pain
General disorders
—
—
Infections and infestations - Other, specify
Infections and infestations
—
—
Upper respiratory infection
Infections and infestations
—
—
Infusion related reaction
Injury, poisoning and procedural complications
—
—
Injury, poisoning and procedural complications - Other, specify
Injury, poisoning and procedural complications
—
—
Cardiac troponin I increased
Investigations
—
—
Platelet count decreased
Investigations
—
—
Hyperkalemia
Metabolism and nutrition disorders
—
—
Tumor lysis syndrome
Metabolism and nutrition disorders
—
—
Arthritis
Musculoskeletal and connective tissue disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Urinary tract obstruction
Renal and urinary disorders
—
—
Other adverse events (206 terms — click to expand)
This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab -- as a possible treatment for chronic lymphocytic leukemia (CLL).
The drugs involved in this study are:
* Acalabrutinib
* Venetoclax
* Obinutuzmab
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
Other recruiting trials for Chronic Lymphocytic Leukemia (CLL)
Currently open trials in the same condition.
NCT07428707 — Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
· EARLY_PHASE1
· recruiting
NCT07205315 — A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-p
· EARLY_PHASE1
· recruiting
NCT06788639 — A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisoca
· recruiting
NCT05908409 — A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
· Phase 1, PHASE2
· recruiting
NCT05724121 — Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
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 Dana-Farber Cancer Institute
Last refreshed: 13 February 2026
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/NCT03580928.