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Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma
In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1 to 3 previous therapies received Bendamustine (90 mg/m(2), day 1 + 2) and...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7306311/ https://www.ncbi.nlm.nih.gov/pubmed/32647802 http://dx.doi.org/10.1097/HS9.0000000000000398 |
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author | Hess, Georg Wagner, Karola Keller, Ulrich La Rosee, Paul Atta, Johannes Hübel, Kai Lerchenmueller, Christian Schoendube, Daniel Witzens-Harig, Mathias Ruckes, Christian Medler, Christoph van Oordt, Christina Klapper, Wolfram Theobald, Matthias Dreyling, Martin |
author_facet | Hess, Georg Wagner, Karola Keller, Ulrich La Rosee, Paul Atta, Johannes Hübel, Kai Lerchenmueller, Christian Schoendube, Daniel Witzens-Harig, Mathias Ruckes, Christian Medler, Christoph van Oordt, Christina Klapper, Wolfram Theobald, Matthias Dreyling, Martin |
author_sort | Hess, Georg |
collection | PubMed |
description | In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1 to 3 previous therapies received Bendamustine (90 mg/m(2), day 1 + 2) and Rituximab (375 mg/m(2), day 1) with Temsirolimus in doses from 25 to 75 mg in phase I and 50 mg Temsirolimus in phase II, added on day 1, 8, 15 of a 28 days cycle. The primary endpoint of the phase II was ORR at the end of treatment. Overall, 39 (29 MCL, 10 FL) patients were included. Median age was 71 years and median pretreatment number was 2. Grade 3/4 non-hematologic adverse events were rare and included hyperglycemia in 3 patients (7%) and angioedema in 2 patients (5%). Infectious complications grade 3/4 were observed in 9 patients (23%). Hematologic grade 3/4 events included leukopenia in 22 (56%), neutropenia in 18 (46%), lymphopenia in 16 (41%) and thrombocytopenia in 14 patients (36%). An objective response (best response) was observed in 33/39 patients (89%; 24 MCL (89%) and 9 FL (90%)), including 14 CR (38%; 12 MCL (36%) and 2 FL (20%)). Median PFS is 1.5y for MCL and 1.82 years for FL, and median OS has not been reached for either entity. This data demonstrates promising efficacy of Temsirolimus in r/r MCL and FL with acceptable toxicity. The BeRT regimen may be used as a treatment option for both entities. |
format | Online Article Text |
id | pubmed-7306311 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-73063112020-07-08 Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma Hess, Georg Wagner, Karola Keller, Ulrich La Rosee, Paul Atta, Johannes Hübel, Kai Lerchenmueller, Christian Schoendube, Daniel Witzens-Harig, Mathias Ruckes, Christian Medler, Christoph van Oordt, Christina Klapper, Wolfram Theobald, Matthias Dreyling, Martin Hemasphere Article In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1 to 3 previous therapies received Bendamustine (90 mg/m(2), day 1 + 2) and Rituximab (375 mg/m(2), day 1) with Temsirolimus in doses from 25 to 75 mg in phase I and 50 mg Temsirolimus in phase II, added on day 1, 8, 15 of a 28 days cycle. The primary endpoint of the phase II was ORR at the end of treatment. Overall, 39 (29 MCL, 10 FL) patients were included. Median age was 71 years and median pretreatment number was 2. Grade 3/4 non-hematologic adverse events were rare and included hyperglycemia in 3 patients (7%) and angioedema in 2 patients (5%). Infectious complications grade 3/4 were observed in 9 patients (23%). Hematologic grade 3/4 events included leukopenia in 22 (56%), neutropenia in 18 (46%), lymphopenia in 16 (41%) and thrombocytopenia in 14 patients (36%). An objective response (best response) was observed in 33/39 patients (89%; 24 MCL (89%) and 9 FL (90%)), including 14 CR (38%; 12 MCL (36%) and 2 FL (20%)). Median PFS is 1.5y for MCL and 1.82 years for FL, and median OS has not been reached for either entity. This data demonstrates promising efficacy of Temsirolimus in r/r MCL and FL with acceptable toxicity. The BeRT regimen may be used as a treatment option for both entities. Wolters Kluwer Health 2020-06-08 /pmc/articles/PMC7306311/ /pubmed/32647802 http://dx.doi.org/10.1097/HS9.0000000000000398 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. http://creativecommons.org/licenses/by-sa/4.0 This is an open access article distributed under the Creative Commons Attribution-ShareAlike License 4.0, which allows others to remix, tweak, and build upon the work, even for commercial purposes, as long as the author is credited and the new creations are licensed under the identical terms. http://creativecommons.org/licenses/by-sa/4.0 |
spellingShingle | Article Hess, Georg Wagner, Karola Keller, Ulrich La Rosee, Paul Atta, Johannes Hübel, Kai Lerchenmueller, Christian Schoendube, Daniel Witzens-Harig, Mathias Ruckes, Christian Medler, Christoph van Oordt, Christina Klapper, Wolfram Theobald, Matthias Dreyling, Martin Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title | Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title_full | Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title_fullStr | Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title_full_unstemmed | Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title_short | Final Results of a Phase I/II Trial of the Combination Bendamustine and Rituximab With Temsirolimus (BeRT) in Relapsed Mantle Cell Lymphoma and Follicular Lymphoma |
title_sort | final results of a phase i/ii trial of the combination bendamustine and rituximab with temsirolimus (bert) in relapsed mantle cell lymphoma and follicular lymphoma |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7306311/ https://www.ncbi.nlm.nih.gov/pubmed/32647802 http://dx.doi.org/10.1097/HS9.0000000000000398 |
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