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NCT00790036 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
742
Enrollment target

NCT00790036: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT00790036 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 742 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00790036, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
742 participants
Enrollment target

Study 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

Primary Outcome

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 o

Interventions

  • DRUG Everolimus
  • DRUG Everolimus Placebo

Trial Details

FieldValue
Enrollment Target 742 participants
Start Date 2009-07-24
Est. Completion 2016-06-15
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00790036 record still lists

NCT00790036 is an interventional study that assigns participants to a tested intervention. The registered 742 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.

NCT00790036 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00790036 about?

NCT00790036 is a clinical study titled "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". 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

What is the current status of trial NCT00790036?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 742 participants. The study started on 2009-07-24. Estimated completion is 2016-06-15.

What interventions are being tested in trial NCT00790036?

The interventions under investigation include: Everolimus (DRUG), Everolimus Placebo (DRUG).

Who is sponsoring clinical trial NCT00790036?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00790036's enrollment target sits among peer trials

742 476th of 2000 higher than 1,525 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00790036, the US trial registry maintained by the National Library of Medicine. NCT00790036 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.