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Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT00869999 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-10-27

Study results available
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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.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Everolimus

Taken orally once daily in the morning

DRUG

rituximab

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

Sponsors & Collaborators

Principal Investigators

  • Jeremy S. Abramson, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869999 on ClinicalTrials.gov