Trial · NCT00790036
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
NCT00790036, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT00790036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00790036
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 742 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Everolimus, Everolimus Placebo
- First posted
- 2008-11-13
- Last updated
- 2017-07-12
- Other registries' IDs
- eudract:2008-000498-40
- Results first posted
- 2017-07-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (DFS) | 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 |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Lymphoma-specific Survival (LSS) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival (DFS) | 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 | Full Analysis Set (FAS) includes all randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of randomization to date of death due to any cause up to around 7 years | Full Analysis Set (FAS) includes all randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Lymphoma-specific Survival (LSS) | From randomization to death documented as a result of lymphoma up to 7 years | Full Analysis Set (FAS) includes all randomized patients. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (DFS) | RAD001 (Everolimus)1 | 77.8 | 95% Confidence Interval 72.7 to 82.1 | Percentage of participants | |
| Disease-free Survival (DFS) | Placebo | 77.0 | 95% Confidence Interval 72.1 to 81.1 | Percentage of participants | |
| Overall Survival (OS) | RAD001 (Everolimus)1 | 2 years | 90.7 | 95% Confidence Interval 87.0 to 93.4 | Percentage of participants |
| Overall Survival (OS) | Placebo | 2 years | 88.3 | 95% Confidence Interval 84.4 to 91.3 | Percentage of participants |
| Overall Survival (OS) | RAD001 (Everolimus)1 | 3 years | 88.0 | 95% Confidence Interval 83.8 to 91.1 | Percentage of participants |
| Overall Survival (OS) | Placebo | 3 years | 83.7 | 95% Confidence Interval 79.3 to 87.3 | Percentage of participants |
| Overall Survival (OS) | RAD001 (Everolimus)1 | 4 years | 85.4 | 95% Confidence Interval 80.7 to 89.1 | Percentage of participants |
| Overall Survival (OS) | Placebo | 4 years | 80.7 | 95% Confidence Interval 75.8 to 84.7 | Percentage of participants |
| Overall Survival (OS) | RAD001 (Everolimus)1 | 5 years | 83.4 | 95% Confidence Interval 78.1 to 87.5 | Percentage of participants |
| Overall Survival (OS) | Placebo | 5 years | 77.4 | 95% Confidence Interval 71.7 to 82.0 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RAD001 (Everolimus)1 | 372 | |
| Overall Study | STARTED | Placebo | 370 | |
| Overall Study | Untreated Participants | RAD001 (Everolimus)1 | 4 | |
| Overall Study | Untreated Participants | Placebo | 6 | |
| Overall Study | COMPLETED | RAD001 (Everolimus)1 | 177 | |
| Overall Study | COMPLETED | Placebo | 249 | |
| Overall Study | NOT COMPLETED | RAD001 (Everolimus)1 | 195 | |
| Overall Study | NOT COMPLETED | Placebo | 121 |
Source ClinicalTrials.gov
Adverse events675
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | RAD001 (Everolimus) | 61 | 368 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 18 | 364 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 79 | 732 | |
| other | Leukopenia | Blood and lymphatic system disorders | RAD001 (Everolimus) | 29 | 368 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 23 | 364 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Patients | 52 | 732 | |
| other | Lymphopenia | Blood and lymphatic system disorders | RAD001 (Everolimus) | 22 | 368 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 13 | 364 | |
| other | Lymphopenia | Blood and lymphatic system disorders | All Patients | 35 | 732 | |
| other | Neutropenia | Blood and lymphatic system disorders | RAD001 (Everolimus) | 89 | 368 |
1 to 10 of 675Source ClinicalTrials.gov
See all 675 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RAD001 (Everolimus) | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | RAD001 (Everolimus) | 348 | 368 |
| Total, other adverse events | Placebo | 276 | 364 |
| Total, other adverse events | All Patients | 624 | 732 |
| Total, serious adverse events | RAD001 (Everolimus) | 105 | 368 |
| Total, serious adverse events | Placebo | 62 | 364 |
| Total, serious adverse events | All Patients | 167 | 732 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29253068 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00790036
GET https://conductscience.org/api/trials/v1/NCT00790036/results?page=2