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

International Extranodal Lymphoma Study Group (IELSG)10 sites in 3 countries30 target enrollmentMarch 2010

ConditionsMarginal Zone B-cell Lymphoma

DrugsEverolimus

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Marginal Zone B-cell Lymphoma
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Enrollment: 30
Locations: 10
Primary Endpoint: Total Body CT-Scan
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and or monoclonal antibodies).
•Any stage (Ann Arbor I-IV).
•No evidence of histologic transformation to aggressive lymphoma.
•Measurable or evaluable disease.
•Age \> 18 years.
•Life expectancy of at least 3 months.
•ECOG performance status 0-
•No prior diagnosis of neoplasm within 5 years, except cervical type 1 intraepithelial neoplasia or localized non-melanomatous skin cancer.
•In case of prior diagnosis of solid organ tumors, no treatment over the last 5 years ond no current evidence of disease.
•No prior chemo-or radiotherapy in the last 6 weeks, no prior immunotherapy in the last 8 weeks, no corticosteroids during the last 4 weeks unless low-dose prednisone chronically administered for indications other than lymphoma or lymphoma-related symptoms.

Exclusion Criteria

•Patients with newly diagnosed MZL.
•Patients with concomitant or past hematological malignancies.
•Presence or history of CNS lymphoma localization (either parenchymal or meningeal disease).
•Cardiovascular disease (congestive heart failure; NYHA III or IV), unstable angina pectoris, significant cardiac arrhythmias requiring chronic treatment, or prior history of myocardial infarction in the last 3 months.
•Serious underlying medical condition which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, ongoing infection e.g. HIV, hepatitis).
•Concurrent anticancer drugs / treatments and experimental drugs. Previous radiation is allowed, unless the indicator lesion(s) are in the irradiated field.
•Previous organ transplantation
•Participation in another clinical trial within 30 days prior to trial entry
•Pregnant or lactating women.