A Phase III Study of Rituximab/Lenalidomide or Rituximab/Chemotherapy Followed by Rituximab Maintenance Therapy in Patients with Previously Untreated Follicular Lymphoma

Protocol
12-081
Full Title
A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects with Previously Untreated Follicular Lymphoma (The "RELEVANCE" trial)
Phase
III
Disease Status
Newly Diagnosed
Purpose

Follicular lymphoma often responds to treatment and then relapses, requiring further treatment. Rituximab plus chemotherapy is the standard treatment for follicular lymphoma, and is often followed by rituximab alone to maintain remission. In this study, researchers want to see if rituximab plus the drug lenalidomide followed by rituximab maintenance therapy is more effective than the standard treatment for patients with previously untreated follicular lymphoma.

Lenalidomide is approved for the treatment of a cancer called multiple myeloma and for myelodysplastic syndromes, but its use for treating follicular lymphoma is considered investigational. In prior clinical trials of previously treated patients, however, the combination of rituximab and lenalidomide was highly active. Lenalidomide alters the immune system and may interfere with the tiny blood vessels that support tumor growth.

Patients in this study will be randomly assigned to receive rituximab plus standard chemotherapy or rituximab plus lenalidomide. Patients will then have maintenance therapy with rituximab alone or rituximab plus lenalidomide.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated stage II-IV follicular lymphoma that is positive for the CD20 protein (the target of rituximab).
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. M. Lia Palomba at 212-639-7186.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases