IIL MCL0208

A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing Rituximab followed by high dose chemotherapy and autologous stem cell transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma

Objectives, structure and design of the Study

Study design

Multicenter, open-label, randomized, controlled Study

Primary objective

To evaluate the efficacy of Lenalidomide as maintenance therapy to prolong progression-free survival after completion of first-line high-dose chemotherapy additioned with Rituximab and followed by autologous stem cell transplantation in adult Patients with Mantle Cell Lymphoma who have achieved complete response or partial response

Secondary objectives

  • To evaluate the overall survival
  • To evaluate disease and event-free survival
  • To evaluate the safety of lenalidomide as maintenance therapy after completion of first-line highdose chemotherapy additioned with rituximab and followed by ASCT in adult patients with MCL who have achieved CR or PR.
  • To evaluate the efficacy and safety of a simplified R-HDS regimen followed by HDC+ASCT as consolidation after R-CHOP induction.
  • To evaluate the overall clinical response at the end of treatment and at the end of study
  • To evaluate the activity of lenalidomide maintenance on minimal residual disease assessed in terms of: rate of conversion to molecular remission, rate of molecular relapse, disease kinetics by real time PCR in the bone marrow (BM) and peripheral blood (PB).
  • To assess the prognostic impact of molecular response, molecular relapse and disease kinetics by real time PCR on PFS
  • To evaluate the quality of life
  • To evaluate the cost-effectiveness of the maintenance with lenalidomide vs observation.

Clinical phase

III

Indication

Adult Patients with MCL who have achieved CR or PR after completion of first-line high-dose chemotherapy additioned with Rituximab and followed by ASCT

Sample size

250 Patients

Primary variable

2-years PFS

Number of Centers and location of the Study

59 FIL sites and 3 international cooperative groups with 10-12 Centers

Study duration

5 years based on the following assumptions:

  1. Recruitment: 36 months
  2. Maximum treatment period: 24 months
  3. Follow-up: 24 months

Study start date

May 2010