Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Completed · Phase 2/Phase 3

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

Key facts

Study ID

NCT01197560

Run by

Celgene

People needed

111

Starts

2010-09-02

Expected to finish

2018-04-05

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
• Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
• Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

You may not qualify if…

• Diagnosis of lymphoma histologies other than DLBCL.
• History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
• Eligible for autologous stem cell transplant.
• Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
• Neuropathy grade 4.

Where it is running

• MD Anderson Cancer Center Orlando — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• University of Michigan, Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Washington University Siteman Cancer Center — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• MD Anderson Houston — Houston, Texas, United States
• Royal Adelaide Hospital — Adelaide, Australia
• Royal Brisbaine and Womens Hospital — Herston, Australia
• Princess Alexandra Hospital — Woolloongabba, Australia
• Innsbruck University Hospital — Innsbruck, Austria
• Universitätsklinikum Salzburg — Salzburg, Austria
• Medical University of Vienna — Vienna, Austria
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• Charles University — Prague, Czechia
• ICH CHU Brest- C.H.U. MORAVAN — Brest, France
• CHU de Grenoble-Hopital Albert Michallon — Grenoble, France
• Chd -Vendee — La Roche-sur-Yon, France
• Centre Hospitalier Lyon Sud — Lyon, France
• Providence St Joseph Medical Center/Cancer Center — Burbank, California, United States

Full record on ClinicalTrials.gov

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