Helmholtz Gemeinschaft

Search
Browse
Statistics
Feeds

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

[thumbnail of Original Article]
Preview
PDF (Original Article) - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
785kB

Item Type:Article
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
Creators Name:Hess, G., Wagner, K., Keller, U., La Rosee, P., Atta, J., Hübel, K., Lerchenmueller, C., Schoendube, D., Witzens-Harig, M., Ruckes, C., Medler, C., van Oordt, C., Klapper, W., Theobald, M. and Dreyling, M.
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%), 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.
Source:HemaSphere
ISSN:2572-9241
Publisher:Wolters Kluwer
Volume:4
Number:3
Page Range:e398
Date:June 2020
Official Publication:https://doi.org/10.1097/HS9.0000000000000398
PubMed:View item in PubMed

Repository Staff Only: item control page

Downloads

Downloads per month over past year

Open Access
MDC Library