NCT01665768

Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas, Gray Zone Lymphoma, and Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.

Detailed description

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.

Conditions

• CD20+, B-cell Lymphomas
• Mantle Cell Lymphoma
• Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL)
• Transformed Lymphoma/DLBCL/PMBCL
• Hodgkin's Disease
• Gray Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Everolimus	The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL.
BIOLOGICAL	Rituximab	375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-10-01
• Completion: 2020-08-01
• First posted: 2012-08-15
• Last updated: 2021-10-26
• Results posted: 2018-12-26

Locations

1 site across 1 country: United States