Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01665768|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2012
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Everolimus and Rituximab||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Everolimus and Rituximab
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.
Drug: Everolimus and Rituximab
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 Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
Other Name: RAD001
- Number of patients with adverse events when given treatment with maintenance rituximab and prolonged mTOR inhibition with everolimus in CD20+, B cell lymphomas, Gray Zone Lymphoma, and Hodgkin's Lymphoma after high-dose consolidative therapy• Avoidance of ≥ grade III common toxicities (CTCAE version 4.0)
- 1) Event free survival at three years based on histology [ Time Frame: 3 years ]• EFS will be histology grade specific: Mantle cell lymphoma group, low-grade lymphoma group, high-grade lymphoma group
- 2) Reduction of the frequency of circulating cancer cells due to maintenance rituximab with everolimus treatment
- 3) Sensitivity, in-vivo, of relapsed disease to mTor kinase inhibition.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665768
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Douglas Gladstone, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|