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 (PILLAR2)
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|ClinicalTrials.gov Identifier: NCT00790036|
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Everolimus Drug: Everolimus Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||742 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||July 24, 2009|
|Actual Primary Completion Date :||June 15, 2016|
|Actual Study Completion Date :||June 15, 2016|
Participants who received Everolimus 10 mg (two 5 mg tablets), daily for 12 months
Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
Other Name: RAD001
Placebo Comparator: Placebo
Participants who received Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
Drug: Everolimus Placebo
Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
- Disease-free Survival (DFS) [ Time Frame: From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years ]DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy
- Overall Survival (OS) [ Time Frame: From date of randomization to date of death due to any cause up to around 7 years ]OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.
- Lymphoma-specific Survival (LSS) [ Time Frame: From randomization to death documented as a result of lymphoma up to 7 years ]LSS was defined as time from randomization to death as a result of lymphoma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790036
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|