A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens. The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Lenalidomide: Dose escalation 10 /15 /20 /25mg/d d1-21 q28d; for 6 treatment cycles Vorinostat: 400 mg d1-21 q28d, for 6 treatment cycles
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
Krankenhaus der Stadt Linz
Linz, Austria
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria
The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.
Time frame: 6 months
Remission rate of a combination therapy with Lenalidomide, Vorinostat, and Dexamethasone in a treatment refractory or relapsed population, defined as the percentage of patients achieving a complete response (CR) or partial response (PR)
Time frame: 6 months
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Hanusch Krankenhaus
Vienna, Austria