Hess, Georg, Wagner, Karola, Keller, Ulrich, La Rosee, Paul, Atta, Johannes, Huebel, Kai, Lerchenmueller, Christian, Schoendube, Daniel, Witzens-Harig, Mathias, Ruckes, Christian, Medler, Christoph, van Oordt, Christina, Klapper, Wolfram, Theobald, Matthias and Dreyling, Martin (2020). 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. Hemasphere, 4 (3). PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 2572-9241

Full text not available from this repository.

Abstract

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%), lyrnphopenia 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Hess, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wagner, KarolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keller, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
La Rosee, PaulUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Atta, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huebel, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lerchenmueller, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schoendube, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witzens-Harig, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruckes, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Medler, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Oordt, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klapper, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Theobald, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-331322
DOI: 10.1097/HS9.0000000000000398
Journal or Publication Title: Hemasphere
Volume: 4
Number: 3
Date: 2020
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 2572-9241
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SINGLE-AGENT TEMSIROLIMUS; INVESTIGATORS CHOICE; PLUS RITUXIMAB; MAMMALIAN TARGET; RESPONSE RATE; OPEN-LABEL; II TRIAL; B-CELL; R-CHOP; MULTICENTERMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/33132

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item