Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
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|ClinicalTrials.gov Identifier: NCT01665768|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2012
Results First Posted : December 26, 2018
Last Update Posted : December 26, 2018
|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 Biological: 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 :||56 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|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||November 2019|
Experimental: Everolimus and Rituximab
Everolimus daily for one year and IV rituximab four times during that year.
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.
Other Name: RAD001
375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
Other Name: Rituxan
- Safety as Assessed by Avoidance of Grade 3-4 Adverse Events [ Time Frame: Up to 3 years ]Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0.
- Event Free Survival (EFS) [ Time Frame: 2.5 years ]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.
- Reduction of the Frequency of Circulating Cancer Cells [ Time Frame: 1 year, 2 years, and 3 years ]Percentage change in circulating cancer cells between baseline and each timepoint noted below.
- Sensitivity of Relapsed Disease to mTOR Kinase Inhibition [ Time Frame: 1 year, 2 years, and 3 years ]Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|