FIL R2-B

Bendamustine, Lenalidomide and Rituximab (R2-B) combination as a second-line therapy for first relapsed-refractory mantle cell lymphomas: a phase II study

Obiettivi, struttura e articolazione dello Studio

Disegno dello Studio

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction.

Scopo primario

1. To explore the antitumor activity of the association of R2-B in terms of complete response (CR) in patients with relapsed/refractory MCL to a first line of therapy.
2. To evaluate the efficacy of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding (CR or PR) to the induction, in terms of progression free survival (maPFS).

Obiettivi secondari

1. To evaluate the safety profile;
2. To evaluate the molecular response (MR);
3. To evaluate the overall response (OR);
4. To evaluate the effect of treatment on Progression Free Survival (PFS);
5. To evaluate the effect of treatment on Overall Survival (OS);
6. To estimate the cumulative incidence of second primary malignancies (hematological and not-hematological).

Fase clinica

II

Indicazione

Treatment of patients with MCL in first relapse or refractory after a first line of chemotherapy.

Dimensione del campione

42 Pazienti

Numero di Centri e localizzazione dello Studio

53 Centri in Italia

Durata dello Studio

60 months sulla base delle seguenti assunzioni:

1. Reclutamento: 18 mesi
2. Massimo periodo di trattamento: 24 mesi
3. Follow up: 18 mesi

Data di inizio dello Studio

March 2012