Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. Diffuse Large B-cell Lymphoma (DLBCL)is just one type of lymphoma. Within Diffuse Large B-cell Lymphoma (DLBCL) there are two different subtypes called GCB and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and to doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both.

This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs.

Eligibility Criteria

Inclusion Criteria:

• Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).

• Relapsed or refractory to combination chemotherapy for Diffuse Large B-Cell Lymphoma (DLBCL) that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.

• Measurable Diffuse Large B-Cell Lymphoma (DLBCL)disease by Computed Tomograph(CT) / Magnetic Resonance Imagining (MRI).

• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

• Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).

• History of malignancies, other than Diffuse Large B-Cell Lymphoma (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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

Oliver Manzke, MD

Study Director

Shanti Varughese		Ph: 908-673-2331
		Email: svarughese@celgene.com

U.S.A.
California
	Burbank
	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
Illinois
	Chicago
	Rush Cancer Institute at Rush University Medical Center
Maryland
	Bethesda
	Center for Cancer and Blood Disorders
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
Mississippi
	Hattiesburg
	Hattiesburg Clinic
Missouri
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
New York
	Buffalo
	Roswell Park Cancer Institute
Tennessee
	Nashville
	Vanderbilt -Ingram Cancer Center
Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
	Herston
	Royal Brisbaine and Womens Hospital
	Woolloongabba
	Princess Alexandra Hospital
Czech Republic
	Hradec Kralove 5
	University Hospital Hradec Kralove
	Praha
	Charles University
France
	Brest Cedex 2
	ICH CHU Brest- C.H.U. MORAVAN
	Grenoble
	CHU de Grenoble-Hopital Albert Michallon
	La Roche Sur Yon
	Chd -Vendee
	Lyon
	Centre Hospitalier Lyon Sud
	Marsielle
	Institute Paoli-Calmette
	Nantes Cedex 1
	Hotel Dieu
	Pessac
	CHRU-Hopital du Haut -Leveque
	Rennes
	Centre Hospitalier Universitaire de Rennes
	Toulouse
	Centre Hospitalier Regional de Purpan
	Vandoeuvre-les Nancy cedex
	Hopital de Brabois Adultes
Italy
	Bologna
	Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico
	Firenze
	Azienda Ospedaliera Universitaria Careggi
	Genova
	Ospedale San Martino
	Miano
	Ieo istituto Europeo di Oncologia
	Napoli
	Azienda Ospedaliera Universitaria "Frederico II"
	Pavia
	Fondazione I.R.C.C.S. Policlinico San Matteo
	Rionero in Vulture (PZ)
	Irccs/Crob
	Roma
	Policlinico Tor Vergata (Universta Tor Vergata)
	Terni
	Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri
Spain
	Barcelona
	Vall d'Hebron University Hospital
	Cordoba
	Hospital Universarito Reina Sofia
	Marbella
	Hospital Costa Del Sol
	Ourense
	CH de Orense
	Pamplona
	Hospital de Navarra
	Salamanca
	Hosptial Clinico Universitario de Salamanca
Sweden
	Umea
	Onkologiska kliniken
	Uppsala
	Onkologiklinken
United Kingdom
	Bournemouth
	Royal Bournemouth Hospital Haematology
	Exeter
	Royal Devon and Exeter Hospital Haematology Department
	Leeds
	St. James Institute of Oncology
	London
	Royal Mardsen Hospital - Fulham (Satellite Site)
	Manchester
	The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team
	Plymouth
	Derrford Hospital
	Southhampton
	Southhampton University Hospital NHS Trust
	Sutton
	Royal Mardsen NHS Foundation Trust

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01197560
Information obtained from ClinicalTrials.gov on June 27, 2012

Back to Top