This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).
Ospedale SS. Antonio Biagio e Cesare Arrigo
Alessandria, Italy
Centro diriferimento oncologico
Aviano (PN), Italy
To explore the antitumor activity of the association of Len-Dex in term of overall (OR) and complete response (CR) in patients with relapsed/refractory MCL
Time frame: 3 years
To explore the safety profile;
Time frame: 2 years
To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy;
Time frame: 2 years
To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS).
Time frame: 2 years
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