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Ibrutinib, lenalido...
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Jerkeman, MatsLund University,Lunds universitet,Lymfom - Klinisk forskning,Forskargrupper vid Lunds universitet,Lymphoma - Clinical Research,Lund University Research Groups,Skåne University Hospital
(author)
Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON) : a multicentre, open-label, single-arm, phase 2 trial
- Article/chapterEnglish2018
Publisher, publication year, extent ...
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ELSEVIER SCI LTD,2018
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-350496
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-350496URI
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https://doi.org/10.1016/S2352-3026(18)30018-8DOI
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https://lup.lub.lu.se/record/c801db77-dcf8-4689-9cc8-e694011abd10URI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Background Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. Methods In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0-3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters. Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only (cycle duration 56 days), given until disease progression or unacceptable toxicity. In the induction phase, patients received intravenous (375 mg/m(2)) or subcutaneous (1400 mg) rituximab once a week during cycle 1 and then once every 8 weeks. Oral ibrutinib (560 mg once a day) was given to patients every day in the cycle, whereas oral lenalidomide (15 mg once a day) was given on days 1-21. The primary endpoint was overall response assessed in the intention-totreat population according to Lugano criteria. Safety analysis included all patients who received the treatment, irrespective of eligibility or duration of treatment. The trial is ongoing, but is no longer accruing patients, and is registered with ClinicalTrials. gov, number NCT02460276. Findings Between April 30, 2015, and June 1, 2016, we enrolled 50 patients with relapsed or refractory mantle cell lymphoma at ten centres in Sweden, Finland, Norway, and Denmark. At a median follow-up of 17.8 months (IQR 14.7-20.9), 38 (76%, 95% CI 63-86) patients had an overall response, including 28 (56%, 42-69) patients who had a complete response and ten (20%, 11-33) who had a partial response. The most common grade 3-4 adverse events were neutropenia (in 19 [38%] of 50 patients), infections (in 11 [22%] patients), and cutaneous toxicity (in seven [14%] patients). There were three treatment-related deaths during the study, two due to sepsis and one due to embolic stroke. Interpretation Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomised controlled trial.
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Added entries (persons, corporate bodies, meetings, titles ...)
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Eskelund, Christian WintherRigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen
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Hutchings, MartinRigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen
(author)
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Raty, RiikkaHelsinki Univ Hosp, Dept Haematol, Helsinki, Finland.,Helsinki University Central Hospital
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Wader, Karin FahlSt Olavs Univ Hosp, Dept Oncol, Trondheim, Norway.,St. Olav’s University Hospital
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Laurell, AnnaUppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital(Swepub:lu)onk-ala
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Toldbod, HelleAarhus Univ Hosp, Clin Trial Off, Dept Haematol, Aarhus, Denmark.,Aarhus University Hospital
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Pedersen, Lone BredoRigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen
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Niemann, Carsten UtoftRigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen
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Dahl, ChristinaDanish Canc Soc, Res Ctr, Copenhagen, Denmark.,Danish Cancer Society
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Kuitunen, HanneOulu Univ Hosp, Dept Oncol, Oulu, Finland.,Oulu University Hospital
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Geisler, Christian H.Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen
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Gronbaek, KirstenRigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.
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Kolstad, ArneOslo Univ Hosp, Dept Oncol, Oslo, Norway.,Oslo university hospital
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Grønbæk, KirstenUniversity of Copenhagen
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Lymfom - Klinisk forskningForskargrupper vid Lunds universitet
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In:Tha Lancet Haematology: ELSEVIER SCI LTD5:3, s. E109-E1162352-3026
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Jerkeman, Mats
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Eskelund, Christ ...
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Hutchings, Marti ...
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Raty, Riikka
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Wader, Karin Fah ...
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Toldbod, Helle
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Kuitunen, Hanne
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Kolstad, Arne
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