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
CompletedPhase 3Results postedLast updated 12 July 2017
What this trial tests
Phase 3 trial testing Everolimus in Diffuse Large B-cell Lymphoma in 742 participants. Completed in 15 June 2016.
18 and older, any sex, with Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease-free Survival (DFS)Primary· 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
Group
Value
95% CI
RAD001 (Everolimus)1
77.8
72.7 – 82.1
Placebo
77.0
72.1 – 81.1
Overall Survival (OS)Secondary· 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.
2 years
Group
Value
95% CI
RAD001 (Everolimus)1
90.7
87.0 – 93.4
Placebo
88.3
84.4 – 91.3
3 years
Group
Value
95% CI
RAD001 (Everolimus)1
88.0
83.8 – 91.1
Placebo
83.7
79.3 – 87.3
4 years
Group
Value
95% CI
RAD001 (Everolimus)1
85.4
80.7 – 89.1
Placebo
80.7
75.8 – 84.7
5 years
Group
Value
95% CI
RAD001 (Everolimus)1
83.4
78.1 – 87.5
Placebo
77.4
71.7 – 82.0
6 years
Group
Value
95% CI
RAD001 (Everolimus)1
80.3
71.6 – 86.6
Placebo
77.4
71.7 – 82.0
Lymphoma-specific Survival (LSS)Secondary· 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.
2 years
Group
Value
95% CI
RAD001 (Everolimus)1
94.9
91.8 – 96.8
Placebo
90.5
86.9 – 93.2
3 years
Group
Value
95% CI
RAD001 (Everolimus)1
93.1
89.6 – 95.5
Placebo
88.8
84.9 – 91.8
4 years
Group
Value
95% CI
RAD001 (Everolimus)1
91.6
87.6 – 94.3
Placebo
86.9
82.6 – 90.3
5 years
Group
Value
95% CI
RAD001 (Everolimus)1
89.4
84.6 – 92.8
Placebo
85.4
80.5 – 89.2
6 years
Group
Value
95% CI
RAD001 (Everolimus)1
89.4
84.6 – 92.8
Placebo
85.4
80.5 – 89.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
· EARLY_PHASE1
· recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
· Phase 1
· not yet recruiting
NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
· Phase 2
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06832189 — EVR and EPO for Liver Transplant Tolerance
· Phase 1
· recruiting
Other recruiting trials for Diffuse Large B-cell Lymphoma
Currently open trials in the same condition.
NCT06977711 — Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large
· Phase 1
· recruiting
NCT06846463 — Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
· Phase 2
· recruiting
NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers
· Phase 1
· active not recruiting
NCT06651853 — Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
· Phase 2
· recruiting
NCT06503263 — Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
· Phase 2
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 12 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00790036.