Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine clinical efficacy of Everolimus in combination with rituximab in relapsed/refractory DLBCL
Jeremy S. Abramson, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Israel Deaconsess Medical Center||Boston, Massachusetts 02215|