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A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study has been terminated.
(Business decision)
Information provided by:
Celgene Identifier:
First received: May 14, 2007
Last updated: August 27, 2009
Last verified: August 2009
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: CC-5013 (lenalidomide)
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • Tumor Response Rate [ Time Frame: One Year ]

Secondary Outcome Measures:
  • Tumor Control Rate [ Time Frame: One Year ]
  • Duration of Response [ Time Frame: One year ]
  • Time to Progression [ Time Frame: One year ]
  • Progression-free Survival [ Time Frame: One year ]

Enrollment: 26
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: CC-5013 (lenalidomide)
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
Other Names:
  • CC-5013
  • lenalidomide
  • Revlimid
Drug: dexamethasone
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
Other Name: Decadron

Detailed Description:

Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
  • Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
  • Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  • ECOG performance score of 0,1 or 2
  • Willing to follow the pregnancy precautions

Exclusion Criteria:

  • Any of the following laboratory abnormalities.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
  • Platelet count < 60,000/mm3 (60 x 109/L).
  • Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
  • Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
  • History of active CNS lymphoma within the previous 3 months
  • Subjects not willing or unable to take DVT prophylaxis
  • History of other malignancies within the past year
  • Positive HIV or active Hepatitis B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00474188

  Hide Study Locations
United States, Arizona
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, United States, 85304
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
Hematology/Oncology Associates of Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Illinois
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, United States, 60005
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Southwest Oncology Associates
Lafayette, Louisiana, United States, 70503
United States, Maryland
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, United States, 21742
United States, Michigan
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, United States, 49048
United States, New Jersey
Oncology & Hematology Specialists, PA
Denville, New Jersey, United States, 07834
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Northwestern Carolina, Oncology and Hematology PA
Hickory, North Carolina, United States, 28602
New Bern Cancer Care
New Bern, North Carolina, United States, 28562
United States, Ohio
James Cancer Hospital
Columbus, Ohio, United States, 43210
United States, Texas
SouthWest Regional Cancer Center
Austin, Texas, United States, 78705
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, VIC3050
Frankston Hospital
Frankston, Australia, VIC 3199
South Brisbane, Australia, QLD 4101
Border Medical Oncology
Wodonga, Australia, VIC 3690
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Celgene Corporation
Principal Investigator: Andrew Spencer, MD The Alfred
  More Information

Responsible Party: Robert Knight, M.D., Celgene/sponsor Identifier: NCT00474188     History of Changes
Other Study ID Numbers: CC-5013-NHL-005
Study First Received: May 14, 2007
Results First Received: June 30, 2009
Last Updated: August 27, 2009

Keywords provided by Celgene:
Diffuse Large B-cell lymphoma
Non-Hodgkins lymphoma
Response Rate
Tumor Control Rate
Duration of Response
Time to Progression
Progression-free survival and safety

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Autonomic Agents processed this record on March 27, 2017