{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T15:00:47Z","timestamp":1790521247505,"version":"4.1.0"},"reference-count":31,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"23","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2018,8,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> The Bruton's tyrosine kinase inhibitor ibrutinib has demonstrated clinical activity in B-cell malignancies. The DAWN study assessed the efficacy and safety of single-agent ibrutinib in chemoimmunotherapy relapsed\/refractory follicular lymphoma (FL) patients. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> DAWN was an open-label, single-arm, phase II study of ibrutinib in patients with FL with two or more prior lines of therapy. Patients received ibrutinib 560 mg daily until progressive disease\/unacceptable toxicity. The primary objective was independent review committee\u2013assessed overall response rate (ORR; complete response plus partial response). Exploratory analyses of T-cell subsets in peripheral blood (baseline\/cycle 3) and cytokines\/chemokines (baseline\/cycle 2) were performed for available samples. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Between March 2013 and May 2016, 110 patients with a median of three prior lines of therapy were enrolled. At median follow-up of 27.7 months, ORR was 20.9% (95% CI, 13.7% to 29.7%, which did not meet the 18% lower-bound threshold for the primary end point). Twelve patients achieved a complete response (11%; 95% CI, 5.8% to 18.3%). Median duration of response was 19.4 months (range, 1 to \u2265 33 months), with a median progression-free survival of 4.6 months and a 30-month overall survival of 61% (95% CI, 0.51% to 0.70%). Lymphoma symptoms resolved in 67%. Seven of 32 patients who experienced initial radiologic progression responded upon continuing therapy (pseudoprogression). The most common adverse events were diarrhea, fatigue, cough, and muscle spasms; 48.2% of patients reported serious adverse events. In patients who experienced a response, regulatory T cells were downregulated at C3D1 ( P = .02), and Th1-promoting (antitumor) cytokines interferon-\u03b3 and interleukin-12 increased ( P \u2264 .035). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> With an ORR of 20.9%, ibrutinib failed to meet its primary efficacy end point in chemoimmunotherapy in patients with relapsed\/refractory FL, although responses were durable and associated with a reduction in regulatory T cells and increases in proinflammatory cytokines. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2017.76.8853","type":"journal-article","created":{"date-parts":[[2018,5,31]],"date-time":"2018-05-31T20:00:04Z","timestamp":1527796804000},"page":"2405-2412","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":99,"title":["Ibrutinib as Treatment for Patients With Relapsed\/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study"],"prefix":"10.1200","volume":"36","author":[{"given":"Ajay K.","family":"Gopal","sequence":"first","affiliation":[{"name":"Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. Damle, Michael Schaffer, and Sriram Balasubramanian, Janssen Research & Development, Spring House, PA; Nathan H. Fowler, The University of Texas MD Anderson Cancer..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J.","family":"Schuster","sequence":"additional","affiliation":[{"name":"Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. Damle, Michael Schaffer, and Sriram Balasubramanian, Janssen Research & Development, Spring House, PA; Nathan H. Fowler, The University of Texas MD Anderson Cancer..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan H.","family":"Fowler","sequence":"additional","affiliation":[{"name":"Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. Damle, Michael Schaffer, and Sriram Balasubramanian, Janssen Research & Development, Spring House, PA; Nathan H. Fowler, The University of Texas MD Anderson Cancer..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Trotman","sequence":"additional","affiliation":[{"name":"Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. Damle, Michael Schaffer, and Sriram Balasubramanian, Janssen Research & Development, Spring House, PA; Nathan H. Fowler, The University of Texas MD Anderson Cancer..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Hess","sequence":"additional","affiliation":[{"name":"Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. 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