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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Safety as Assessed by Avoidance of Grade 3-4 Adverse Events
Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0.
Time frame: Up to 3 years
Event Free Survival (EFS)
Percentage of participants alive without disease progression. As defined by Cheson criteria, disease progression is a new lesion or \>= 50% increase in the size of previously identified sites of disease. EFS was estimated using Kaplan-Meier survival analysis.
Time frame: 2.5 years
Percentage Change in the Frequency of Circulating Cancer Cells
Percentage change in circulating cancer cells between baseline and each timepoint noted below.
Time frame: Baseline, 1 year, 2 years and 3 years
Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied
Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below.
Time frame: 1 year, 2 years, and 3 years
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