Valutazione del ruolo della 18F-FDG-PET nella stadiazione e nella valutazione prognostica in pazienti con prima diagnosi di linfoma mantellare arruolati nello studio clinico MCL0208 della Fondazione Italiana Linfomi (FIL)
- To better define the role of PET for the staging of MCL patients at the time of diagnosis (b-PET), for evaluation of res ponse after induction treatment (pre-ASCT; i-PET) and post ASCT (eot-PET) in comparison to the current standards, namely computed axial tomography (CT) and bone marrow biopsy.
- To build a new prognostic model for PFS, including PET parameters, MIPIb and biological data (e.g. MRD, GEP and mutational parameters) to possibly help to plan futures studies to improve the outcome of MCL patients
Duration of the study
- start of PETs collection: Q1/Q2 2021
- completion of PET collection and review Q1/Q2 2022
- end of the study: 1 year after the completion of central review of PETs collected (Q1/Q2 2023)
Number of patients
A sample size of about 200 patients with b-PET and both i-PET and eot-PET is expected to be available for the analysis.
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
Obiettivi, struttura e articolazione dello Studio
Disegno dello Studio
Multicenter, open-label, randomized, controlled Study
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
- 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.
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
Dimensione del campione
Numero di Centri e localizzazione dello Studio
59 FIL sites and 3 international cooperative groups with 10-12 Centers
Durata dello Studio
5 years sulla base delle seguenti assunzioni:
- Reclutamento: 36 mesi
- Massimo periodo di trattamento: 24 mesi
- Follow up: 24 mesi
Data di inizio dello Studio