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Lenalidomide-bendamustine-rituximab in untreated mantle cell lymphoma > 65 years, the Nordic Lymphoma Group phase I+II trial NLG-MCL4

Albertsson-Lindblad, Alexandra LU ; Kolstad, Arne ; Laurell, Anna LU ; Räty, Riikka ; Grønbæk, Kirsten ; Sundberg, Jan ; Pedersen, Lone Bredo ; Ralfkiær, Elisabeth ; Karjalainen-Lindsberg, Marja-Liisa and Sundström, Christer , et al. (2016) In Blood 128(14). p.1814-1820
Abstract

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.... (More)

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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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Blood
volume
128
issue
14
pages
1814 - 1820
publisher
American Society of Hematology
external identifiers
  • wos:000385737900008
  • scopus:84990858946
  • pmid:27354719
ISSN
1528-0020
DOI
10.1182/blood-2016-03-704023
language
English
LU publication?
yes
id
6814bc18-aa01-4ffd-b682-e1da5f3ca0c9
date added to LUP
2016-10-13 15:09:10
date last changed
2024-09-07 22:48:51
@article{6814bc18-aa01-4ffd-b682-e1da5f3ca0c9,
  abstract     = {{<p>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 &gt;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.</p>}},
  author       = {{Albertsson-Lindblad, Alexandra and Kolstad, Arne and Laurell, Anna and Räty, Riikka and Grønbæk, Kirsten and Sundberg, Jan and Pedersen, Lone Bredo and Ralfkiær, Elisabeth and Karjalainen-Lindsberg, Marja-Liisa and Sundström, Christer and Ehinger, Mats and Geisler, Christian and Jerkeman, Mats}},
  issn         = {{1528-0020}},
  language     = {{eng}},
  month        = {{06}},
  number       = {{14}},
  pages        = {{1814--1820}},
  publisher    = {{American Society of Hematology}},
  series       = {{Blood}},
  title        = {{Lenalidomide-bendamustine-rituximab in untreated mantle cell lymphoma > 65 years, the Nordic Lymphoma Group phase I+II trial NLG-MCL4}},
  url          = {{https://lup.lub.lu.se/search/files/20480758/15508959.pdf}},
  doi          = {{10.1182/blood-2016-03-704023}},
  volume       = {{128}},
  year         = {{2016}},
}