Trial reportBlood2025
Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN.
Trial report in Blood, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02475681 (A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Second Primary Malignancies in Patients With B-Cell Lymphomas Treated With Bruton's Tyrosine Kinase Inhibitors: A Systematic Review and Meta-Analysis.European journal of haematology · 2026Pooled it
- Indirect Comparison of the Efficacy of Zanubrutinib vs Ibrutinib and Acalabrutinib in Treatment-Naive Chronic Lymphocytic Leukemia: 6-Year Follow-Up.Advances in therapy · 2026Pooled it
- Final phase 2 study results of acalabrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia.Blood advances · 2026Trial
- Acalabrutinib vs chlorambucil plus rituximab in untreated chronic lymphocytic leukemia: A randomized phase 3 Asian study.Annals of hematology · 2026Trial
- Evaluation of the comparative efficacy and safety of obinutuzumab and other follow-up strategies after rituximab failure in refractory nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2026Article
- Comment on "EHA Guidelines on management of chronic lymphocytic leukemia and Richter transformation".HemaSphere · 2026Article
- Glucosylceramide synthase is required for C6-ceramide nanoliposome-induced organelle stress and cell death.bioRxiv : the preprint server for biology · 2026Article
- Article
- Real-world effectiveness and safety of acalabrutinib in chronic lymphocytic leukaemia: Multicentre experience.British journal of haematology · 2026Observational
- The place of acalabrutinib-obinutuzumab combination in the first-line treatment of patients with chronic lymphocytic leukemia.Translational cancer research · 2026Article
- First-Line Treatment of IGHV-Unmutated Chronic Lymphocytic Leukemia: A Network Meta-Analysis of Targeted and Chemoimmunotherapy Regimens.European journal of haematology · 2026Article
- Outcomes of patients with chronic lymphocytic leukemia discontinuing covalent Bruton tyrosine kinase inhibitors due to adverse events.Leukemia · 2026Article
- Australasian chronic lymphocytic leukaemia consensus statement: 2026 update.Internal medicine journal · 2026Article
- Acalabrutinib monotherapy as a first-line treatment for CLL: 3-year follow-up of the real-world EPIC study.Blood advances · 2026Article
- Surrogate Endpoints in CLL: From Promise and Pitfalls to a Context-Specific Validation Framework.Hematology reports · 2026Review
- Review
- Article
- Novel BTK inhibitors and degraders for relapsed/refractory CLL/SLL: latest updates from ASH 2025 annual meeting.Journal of hematology & oncology · 2026Article
- Real-World Selection of Venetoclax-Obinutuzumab Versus BTK Inhibitor Therapy for Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.European journal of haematology · 2026Article
- Acalabrutinib in Chronic Lymphocytic Leukemia: Pharmacology and Emerging Clinical Perspectives.European journal of haematology · 2026Review
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
27 authors.
Funding
Abstract
abstractAcalabrutinib is a Bruton tyrosine kinase inhibitor approved for the treatment of chronic lymphocytic leukemia. We present results from ELEVATE-TN after a median follow-up of 74.5 months. Overall, 535 patients were randomized (acalabrutinib-obinutuzumab, n = 179; acalabrutinib, n = 179; chlorambucil-obinutuzumab, n = 177). Median age was 70 years, 63.0% had unmutated immunoglobulin heavy chain variable region gene (uIGHV), 13.6% had del(17p) and/or mutated TP53, and 17% had complex karyotype (CK; ≥3 chromosomal abnormalities). Median progression-free survival (PFS) was not reached (NR) for acalabrutinib-obinutuzumab and acalabrutinib vs 27.8 months for chlorambucil-obinutuzumab (both P < .0001); estimated 72-month overall PFS rates were 78.0%, 61.5%, and 17.2%, respectively. Acalabrutinib-obinutuzumab resulted in improved PFS vs acalabrutinib monotherapy (hazard ratio [HR], 0.58; P = .0229). Patients with uIGHV, del(17p) and/or mutated TP53, or CK had significantly improved PFS with acalabrutinib ± obinutuzumab vs chlorambucil-obinutuzumab (P < .0001, P ≤ .0009, and P < .0001 for both acalabrutinib-containing arms, respectively). Median overall survival (OS) was NR for all treatments, with significantly longer OS for acalabrutinib-obinutuzumab than chlorambucil-obinutuzumab (HR, 0.62; P = .0349). Estimated 72-month OS rates were 83.9%, 75.5%, and 74.7% for acalabrutinib-obinutuzumab, acalabrutinib, and chlorambucil-obinutuzumab, respectively. Adverse events (AEs) occurring after >4 years were mostly grade 1 to 2. Rates of AEs, serious AEs, and events of clinical interest were similar between acalabrutinib-containing arms and consistent with the known safety profiles of acalabrutinib and obinutuzumab. Efficacy and safety of acalabrutinib-containing arms were maintained, with longer PFS in both acalabrutinib arms than chlorambucil-obinutuzumab including in patients with high-risk features. This trial was registered at www.ClinicalTrials.gov as #NCT02475681.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.