A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma
A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Indolent lymphoma is a slow growing but incurable lymphoma which includes follicular lymphoma and marginal zone lymphoma. Follicular lymphoma and marginal zone lymphoma are cancers of the B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug that affects the immune system) which alters the body's immune system and it may also interfere with the development of tiny blood vessels involved in tumor growth. Therefore, lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been shown to restore the immune cells' ability to attack and kill tumor cells, an ability that may be inhibited by follicular lymphoma and other lymphomas. The combination of rituximab and lenalidomide may eliminate the cancer while restoring the immune system's ability to attack tumor cells.
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St. Petersburg, Florida 33705, United States
Hackensack, New Jersey 07601, United States
Spartanburg, South Carolina 29303, United States
Porto Alegre, Rio Grande do Sul 90035-001, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Porto Alegre, Rio Grande do Sul 90740-340, Brazil
Jau/SP, São Paulo 17210-080, Brazil
Nanjing, 210029, China
Catania, 95124, Italy
Naples, 80131, Italy
Minato-ku, Tokyo 105-8470, Japan
Sendai, 980-8574, Japan
Saint Petersburg, 197341, Russia
Tula, 300053, Russia
Umuttepe Kocaeli, 41380, Turkey (Türkiye)
London, EC1M 6BQ, United Kingdom