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Lenalidomide-bendam...
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Albertsson-Lindblad, AlexandraLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
(author)
Lenalidomide-bendamustine-rituximab in untreated mantle cell lymphoma > 65 years, the Nordic Lymphoma Group phase I+II trial NLG-MCL4
- Article/chapterEnglish2016
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American Society of Hematology,2016
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LIBRIS-ID:oai:lup.lub.lu.se:6814bc18-aa01-4ffd-b682-e1da5f3ca0c9
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https://lup.lub.lu.se/record/6814bc18-aa01-4ffd-b682-e1da5f3ca0c9URI
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https://doi.org/10.1182/blood-2016-03-704023DOI
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Language:English
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Summary in:English
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For elderly patients with mantle cell lymphoma (MCL), there is no defined standard therapy. In this multicenter open-label phase I/II trial we evaluated the addition of lenalidomide (LEN) to rituximab-bendamustine (R-B) as first-line treatment to elderly MCL patients. Patients >65 years with untreated MCL, stage II-IV were eligible for inclusion. Primary endpoints were maximally tolerable dose (MTD) of LEN, and progression-free survival (PFS). Patients received six cycles q4w of L-B-R (L D1-14, B 90 mg/m(2) iv D1-2 and R 375 mg/m(2) iv D1) followed by single LEN (D1-21, q4w, cycles 7-13). 51 patients (median age 71 years) were enrolled 2009-2013. In phase I, the MTD of LEN was defined as 10 mg in cycles 2-6, and omitted in cycle 1. After six cycles, the complete remission rate (CRR) was 64% and 36% were MRD negative. At a median follow-up time of 31 months, median PFS was 42 months and 3 year overall survival was 73%. Infection was the most common non-hematological grade 3-5 event and occurred in 21 (42%) patients. Opportunistic infections occurred in three patients; 2 PCP and 1 CMV retinitis. Second primary malignancies (SPM) were observed in eight patients (16%). LEN could safely be combined with R-B, when added from the second cycle in patients with MCL, and was associated with a high rate of CR and molecular remission. However, we observed a high degree of severe infections and an unexpected high number of SPMs which may limit its use. http://clinicaltrials.gov: NCT00963534.
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Kolstad, ArneOslo university hospital
(author)
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Laurell, AnnaUppsala University Hospital(Swepub:lu)onk-ala
(author)
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Räty, RiikkaHelsinki University Central Hospital
(author)
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Grønbæk, KirstenCopenhagen University Hospital
(author)
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Sundberg, JanSkåne University Hospital
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Pedersen, Lone BredoCopenhagen University Hospital
(author)
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Ralfkiær, ElisabethCopenhagen University Hospital
(author)
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Karjalainen-Lindsberg, Marja-LiisaUniversity of Helsinki,Helsinki University Central Hospital
(author)
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Sundström, ChristerUppsala University
(author)
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Ehinger, MatsLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)efor-meh
(author)
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Geisler, ChristianCopenhagen University Hospital
(author)
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Jerkeman, MatsLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)onk-mje
(author)
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TumörmikromiljöSektion I
(creator_code:org_t)
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In:Blood: American Society of Hematology128:14, s. 1814-18201528-00200006-4971
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Sundberg, Jan
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