Conditions: Diffuse Large B-cell Lymphoma
Keywords: rituximab everolimus DLBCL mTOR
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.

Detailed description:
Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy.

* Each treatment cycle lasts 28 days (4 weeks). Everolimus will be taken orally, once daily in the morning.
* Rituximab will be administered by an intravenous (IV) infusion on Days 1, 8, 15 and 22 of Cycle 1. In Cycles 2-6, rituximab will be administered only on Day 1 of each cycle.
* Participants will come into the clinic weekly during the first cycle, then on Day 1 of all cycles thereafter. The following tests and procedures will be performed:
* Weekly During Cycle 1: blood tests
* Day 1 of all Subsequent Cycles: brief physical examination; review of current medications, treatments, symptoms and side effects; vital signs; performance status evaluation; blood tests.
* A full body CT and PET scan to assess the participants tumor will be done within 7 days of completing cycles 2, 4, 6, 9 and 12.

Responding subjects may receive up to 6 cycles of Everolimus plus rituximab, and an additional 6 months of oral Everolimus for participants continuing to respond.

Arms:

Interventions: intervention 1: Everolimus intervention 2: rituximab
Intervention descriptions: intervention 1: Taken orally once daily in the morning intervention 2: Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6

Protocol document: