Status:
COMPLETED
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Lead Sponsor:
Celgene
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2018
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01197560
Start Date
September 2 2010
End Date
April 5 2018
Last Update
November 25 2019
Active Locations (57)
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1
Providence St Joseph Medical Center/Cancer Center
Burbank, California, United States, 91505
2
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
3
Emory University
Atlanta, Georgia, United States, 30322
4
Northwestern University
Chicago, Illinois, United States, 60611