Titre
Rituximab, bendamustine, and lenalidomide in patients with aggressive B cell lymphoma not eligible for high-dose chemotherapy or anthracycline-based therapy: phase I results of the SAKK 38/08 trial.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Hitz, F.
Auteure/Auteur
Fischer, N.
Auteure/Auteur
Pabst, T.
Auteure/Auteur
Caspar, C.
Auteure/Auteur
Berthod, G.
Auteure/Auteur
Eckhardt, K.
Auteure/Auteur
Berardi Vilei, S.
Auteure/Auteur
Zucca, E.
Auteure/Auteur
Mey, U.
Auteure/Auteur
Groupes de travail
Swiss Group for Clinical Cancer Research (SAKK) Bern Switzerland
Liens vers les personnes
Liens vers les unités
ISSN
1432-0584
Statut éditorial
Publié
Date de publication
2013
Volume
92
Numéro
8
Première page
1033
Dernière page/numéro d’article
1040
Langue
anglais
Notes
Publication types: Journal ArticlePublication Status: ppublish. pdf type: ORIGINAL ARTICLE
Résumé
This phase I trial was designed to develop a new effective and well-tolerated regimen for patients with aggressive B cell lymphoma not eligible for front-line anthracycline-based chemotherapy or aggressive second-line treatment strategies. The combination of rituximab (375 mg/m(2) on day 1), bendamustine (70 mg/m(2) on days 1 and 2), and lenalidomide was tested with a dose escalation of lenalidomide at three dose levels (10, 15, or 20 mg/day) using a 3 + 3 design. Courses were repeated every 4 weeks. The recommended dose was defined as one level below the dose level identifying ≥2/6 patients with a dose-limiting toxicity (DLT) during the first cycle. Thirteen patients were eligible for analysis. Median age was 77 years. WHO performance status was 0 or 1 in 12 patients. The Charlson Comorbidity Index showed relevant comorbidities in all patients. Two DLTs occurred at the second dose level (15 mg/day) within the first cycle: one patient had prolonged grade 3 neutropenia, and one patient experienced grade 4 cardiac adverse event (myocardial infarction). Additional grade 3 and 4 toxicities were as follows: neutropenia (31 %), thrombocytopenia (23 %), cardiac toxicity (31 %), fatigue (15 %), and rash (15 %). The dose of lenalidomide of 10 mg/day was recommended for a subsequent phase II in combination with rituximab 375 mg/m(2) on day 1 and bendamustine 70 mg/m(2) on days 1 and 2.
PID Serval
serval:BIB_9EE26C5FC900
PMID
Date de création
2013-08-11T07:20:29.642Z
Date de création dans IRIS
2025-05-21T02:49:44Z