Clinical Trial: Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 2009-01

Brief Summary:

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.

Detailed Summary:
Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Current Primary Outcome: Total Body CT-Scan [ Time Frame: Every 12 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: International Extranodal Lymphoma Study Group (IELSG)

Dates:
Date Received: July 15, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 21, 2013
Last Verified: May 2012