Bendamustine, Lenalidomide and Rituximab (R2-B) combination as a second-line therapy for first relapsed-refractory mantle cell lymphomas: a phase II study
Objectives, structure and design of the Study
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.
- 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.
- 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).
- To evaluate the safety profile;
- To evaluate the molecular response (MR);
- To evaluate the overall response (OR);
- To evaluate the effect of treatment on Progression Free Survival (PFS);
- To evaluate the effect of treatment on Overall Survival (OS);
- To estimate the cumulative incidence of second primary malignancies (hematological and not-hematological).
Treatment of patients with MCL in first relapse or refractory after a first line of chemotherapy.
Number of Centers and location of the Study
53 Centers in Italy
60 months based on the following assumptions:
- Recruitment: 18 months
- Maximum treatment period: 24 months
- Follow-up: 18 months
Study start date