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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:September 1, 2010
End Date:April 5, 2018

Use our guide to learn which trials are right for you!

A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

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.

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. DLBCL is just one type of lymphoma. Within DLBCL there are two different
subtypes called Germinal Center B-cell (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 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.

On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and
enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013
data cutoff date. According to the Stage 1 results as assessed by the independent response
adjudication committee (IRAC), neither subtype met the pre specified requirement to be
further studied in Stage 2. Additionally, a suitable assay for the selection of participants
for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not
open Stage 2.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
14
sites
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Adelaide,
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
4960 Childrens Place
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials