A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas and Hodgkin's Lymphoma
Everolimus is a pill that interferes with lymphoma cell growth by blocking a cellular
pathway important in causing cancer cells to grow, called mTor. Rituximab is an intravenous
medication that specifically attacks a protein commonly found on lymphoma cells called CD20.
Rituximab is already widely used to treat multiple forms of lymphoma. Moreover, continuing
rituximab after the completion of chemotherapy is already commonly used to help patients
stay in remission longer. Everolimus has been shown in many types of relapsed lymphoma to
decrease the size of lymph nodes by itself. Everolimus is approved by the Food and Drug
Administration (FDA) for the treatment of advanced kidney cancer and subependymal giant cell
astocytoma. It is not approved for use in lymphoma. The use of everolimus in this research
study is investigational. The word "investigational" means that everolimus is not approved
for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of
everolimus in this study.
The combination of everolimus and rituximab for 1 year after high dose therapy is also new.
We believe the combination of these medications right after your chemotherapy will be more
effective in attacking your remaining cancer before they have time to re-grow.
The usual treatment of lymphoma after high-dose chemotherapy is observation. After your
body has fully recovered from the effects of the chemotherapy, you will receive everolimus
daily for one year and IV rituximab four times during that year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events when given treatment with maintenance rituximab and prolonged mTOR inhibition with everolimus in CD20+, B cell lymphomas and Hodgkin's Lymphoma after high-dose consolidative therapy
• Avoidance of ≥ grade III common toxicities (CTCAE version 4.0)
Douglas Gladstone, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|