CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in 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.

Search/NCT00869999
NCT00869999Phase 2Completed
CompareCT.gov

Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Massachusetts General Hospital·interventional·Posted Mar 26, 2009·Updated Oct 27, 2014

In Brief

A Phase 2 clinical trial evaluating Everolimus and rituximab for Diffuse Large B-cell Lymphoma. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-cell Lymphoma
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Novartis

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.3 years ago

Interventions

Everolimusdrug

Taken orally once daily in the morning

rituximabdrug

Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6