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

Objectives, structure and design of the Study

Study design

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.

Primary objective

  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).

Secondary objectives

  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).

Clinical phase

II

Indication

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

Sample size

42 Patients

Number of Centers and location of the Study

53 Centers in Italy

Study duration

60 months based on the following assumptions:

  1. Recruitment: 18 months
  2. Maximum treatment period: 24 months
  3. Follow-up: 18 months

Study start date

March 2012