At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 742 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Multi-center 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 Have Achieved Complete Response With First-line Rituximab-chemotherapy
In Brief
A Phase 3 clinical trial evaluating Everolimus and Everolimus Placebo for Diffuse Large B-cell Lymphoma. Completed, enrolled 742 participants across 202 sites in 34 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-cell Lymphoma
CountriesArgentina, Australia, Austria, Brazil, Canada, China, Colombia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Lebanon, Mexico, New Zealand, Norway, Peru, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJul 2009
Primary CompletionJun 2016
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartJul 24, 2009
Primary CompletionJun 15, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 17.6 years ago
Interventions
Everolimusdrug
Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Everolimus Placebodrug
Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.