Conditions: Lymphoma, Mantle- Cell
Keywords: Mantle Cell Lymphoma Lymphoma B-Cell Lymphoma Mantle Zone Lymphoma Refractory Lymphoma Aggressive Lymphoma PILLAR-1
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: no

Brief summary:
This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy was determined by the study investigator based on clinical evaluations. Participants were considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.

Detailed description:

Arms:
arm 1: Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.

Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus tablets

Protocol document: