Trial reportLeukemia2019
Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma.
Trial report in Leukemia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 116 citations in OpenAlex.
- Venetoclax Plus Rituximab for Relapse/Refractory Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis of Treatments Available in Brazil.Oncology and therapy · 2026Pooled it
- Venetoclax alone or in combination with other regimens treatment achieve deep and sustained remission of relapsed/refractory chronic lymphocytic leukemia: a meta-analysis.Clinical and experimental medicine · 2022Pooled it
- Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia.Blood advances · 2022Trial
- Trial
- Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.Leukemia & lymphoma · 2020Trial
- Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis.Blood advances · 2020Trial
- Trial
- Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.American journal of hematology · 2019Trial
- Review
- Atrial fibrillation following bendamustine in three lymphoma patients.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2026Article
- Real-world overall survival comparison between first-line Bruton tyrosine kinase inhibitors in treating chronic lymphocytic leukemia/small lymphocytic lymphoma: An analysis of Veterans Health Administration data.Journal of managed care & specialty pharmacy · 2026Article
- Healthcare cost comparison between first-line ibrutinib and acalabrutinib in chronic lymphocytic leukemia patients in the Veterans Affairs.Journal of comparative effectiveness research · 2025Article
- Predicting progression-free survival from measurable residual disease in chronic lymphocytic leukemia.Clinical and translational science · 2024Article
- Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib.Blood advances · 2024Article
- Article
- Comparative safety of novel targeted therapies in relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis.Therapeutic advances in medical oncology · 2024Article
- Network meta-analysis of novel targeted therapies for relapsed/refractory chronic lymphocytic leukemia.Therapeutic advances in medical oncology · 2024Article
- Richter Transformation of Chronic Lymphocytic Leukemia-Are We Making Progress?Current hematologic malignancy reports · 2023Review
- Diagnosis and Management of Cardiovascular Effects of Bruton's Tyrosine Kinase Inhibitors.Current cardiology reports · 2023Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 20 institutions in 15 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1:1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159-0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454-0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 3-4) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.
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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.