Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01164267|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone B-cell Lymphoma||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 2012|
- Total Body CT-Scan [ Time Frame: Every 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164267
|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|