A Trial of maintenance Rituximab with mTor inhibition after High-dose Consolidative Therapy in CD20+, B-cell Lymphomas and Hodgkinï¿½??s Lymphoma
To determine the safety of maintenance rituximab and prolonged mTOR inhibition with everolimus in CD20+, B cell lymphomas and Hodgkinï¿½s Lymphoma after high-dose consolidative therapy. Secondary Objectives are: oThe secondary endpoint of this study is to evaluate event free survival at three years based on histology oTo determine whether maintenance rituximab with everolimus treatment reduces the frequency of circulating cancer cells. oTo determine if relapsed disease is sensitive, in-vivo, to mTor kinase inhibition.
Patients must have had chemotherapy responsive disease (Partial response or better) before high-dose consolidative therapy. This clinical trial is for Mantle cell lymphoma, non-mantle cell low grade B cell Lymphomas (including SLL/CLL), transformed lymphoma, DLBCL, PMBCL, and Hodgkinâ??s Disease.
This clinical trial will begin 6-10 weeks after high dose consolidative therapy. Patient will receive one year of adjuvant rituximab and everolimus. Rituximab will be every 90 days for one year. Everolimus will be daily pill for one year and doses will be adjusted based on trough levels that are monitored. The treatment is broken into 28 day cycles.
05/18/2013 04:02 AM