Trial reportBlood advances2023
Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma.
Trial report in Blood advances, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01974440 (A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
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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, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Invasive fungal infections after Bruton tyrosine kinase inhibitor treatment: a systematic review and meta-analysis.Blood advances · 2026Pooled it
- Cardiac safety profiles of first-generation vs second-generation BTK inhibitors: a meta-analysis.The oncologist · 2026Pooled it
- Long-Term Results of Hematopoietic Cell Transplantation (HCT) for Adults with Blood Disorders- A Systematic Review.Stem cell reviews and reports · 2025Pooled it
- Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Acalabrutinib alone or in combination with rituximab for follicular lymphoma: An open-label study.British journal of haematology · 2024Trial
- Follicular Lymphoma: Novel Therapies and Strategies for Optimal Therapeutic Sequencing.Current oncology reports · 2026Review
- Phase 3 PERSPECTIVE study: Ibrutinib with rituximab for initial treatment of patients with follicular lymphoma.HemaSphere · 2026Article
- Relapsed/Refractory Follicular Lymphoma: Current Advances and Emerging Perspectives.European journal of haematology · 2025Review
- Follicular lymphoma: contemporary clinical management with a focus on recent therapeutic advances.The Korean journal of internal medicine · 2025Review
- Review
- Advances in the Pathogenesis, Diagnosis, Treatment, and Prognosis of Marginal Zone Lymphoma.Current treatment options in oncology · 2025Review
- Covalent Bruton tyrosine kinase inhibitors across generations: A focus on zanubrutinib.Journal of cellular and molecular medicine · 2025Review
- Navigating the changing landscape of BTK-targeted therapies for B cell lymphomas and chronic lymphocytic leukaemia.Nature reviews. Clinical oncology · 2024Review
- Current and future therapies for follicular lymphoma.Experimental hematology & oncology · 2024Review
- Outcomes of marginal zone lymphoma treated with ibrutinib in the first-line setting in the United States: a real-world analysis.Blood advances · 2024Article
- Ibrutinib in the treatment of relapsed FL and MZL?Blood advances · 2023Article
Corrections and comments
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Authors and funding
27 authors at 20 institutions in 17 countries.
Funding
Abstract
The phase 3 SELENE study evaluated ibrutinib + chemoimmunotherapy (CIT; bendamustine and rituximab [BR]; or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Adult patients who had received ≥1 prior line of CIT were randomized 1:1 to oral ibrutinib (560 mg) or placebo daily, plus 6 cycles of BR/R-CHOP. The primary end point was investigator-assessed progression-free survival (PFS). Overall, 403 patients were randomized to ibrutinib + CIT (n = 202) or placebo + CIT (n = 201). Most patients received BR (90.3%) and had FL (86.1%). With a median follow-up of 84 months, median PFS was 40.5 months in the ibrutinib + CIT arm and 23.8 months in the placebo + CIT arm (hazard ratio [HR], 0.806; 95% confidence interval [CI], 0.626-1.037; P = .0922). Median overall survival was not reached in either arm (HR, 0.980; 95% CI, 0.686-1.400). Grade ≥3 treatment-emergent adverse events (TEAEs) were reported in 85.6% and 75.4% of patients in the ibrutinib + CIT and placebo + CIT arms, respectively. In each arm, 13 patients had TEAEs leading to death. The addition of ibrutinib to CIT did not significantly improve PFS compared with placebo + CIT. The safety profile was consistent with known profiles of ibrutinib and CIT. This trial was registered at www.clinicaltrials.gov as #NCT01974440.
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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.