Clinical Trial: Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Salvage Treatment With Lenalidomide and Dexamethaosne(LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Brief Summary: This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).
Detailed Summary:
Sponsor: Fondazione Italiana Linfomi ONLUS
Current Primary Outcome: To explore the antitumor activity of the association of Len-Dex in term of overall (OR) and complete response (CR) in patients with relapsed/refractory MCL [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To explore the safety profile; [ Time Frame: 2 years ]
- To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy; [ Time Frame: 2 years ]
- To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS). [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Fondazione Italiana Linfomi ONLUS
Dates:
Date Received: November 5, 2008
Date Started: July 2008
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016
