Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B cell lymphoma DLBCL poor risk R-IPI 3-5 adjuvant therapy after R-CHOP or R-EPOCH after R-CHOP B-cell lymphoma lymphoma b cells blood cancer lymph nodes Hodgkin's non-Hodgkin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 742
Healthy volunteers: no

Brief summary:
Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

Detailed description:

Arms:
arm 1: Participants who received Everolimus 10 mg (two 5 mg tablets), daily for 12 months arm 2: Participants who received Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months

Interventions: intervention 1: Everolimus intervention 2: Everolimus Placebo
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. intervention 2: Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

Protocol document: