Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)
This is a multicenter open-label uncontrolled phase II study. There are no previous clinical data to estimate the expected response rate of everolimus in MALT lymphomas and in the other less common MZLs (i.e. nodal and splenic) refractory or relapsing after at least 1 prior systemic treatment (chemotherapy or immunotherapy).
The primary objective of this study is to define the antitumor activity, in term of overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of everolimus in relapsed or refractory marginal zone B-cell lymphomas.
The secondary objectives of this study are to assess safety, as acute or long-term toxicity, response duration (RD) (time to relapse or progression) in responders and progression-free survival (PFS) (time to disease progression or death from any cause) in all patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus (RAD001) in Marginal Zone B-cell Lymphomas (MZL) EudraCT Number 2009-011725-14|
|Study Start Date:||March 2010|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|General Hospital AKH|
|Policlinico S. Orsola Malpighi|
|San Raffaele Hospital|
|AOU Maggiore della Carità|
|IRCCS Policlinico S. Matteo|
|AOU S. Giovanni Battista|
|Study Chair:||Emanuele Zucca, MD||IOSI|
|Study Chair:||Annarita Conconi, MD||AOU Maggiore della Carità Novara|