A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT00474188
Last Updated: 2009-09-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2007-05-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
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
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Responsible Party
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Celgene/sponsor
Principal Investigators
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Andrew Spencer, MD
Role: PRINCIPAL_INVESTIGATOR
The Alfred
Locations
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Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Advanced Medical Specialties
Miami, Florida, United States
Hematology/Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Southwest Oncology Associates
Lafayette, Louisiana, United States
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, United States
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, United States
Oncology & Hematology Specialists, PA
Denville, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Northwestern Carolina, Oncology and Hematology PA
Hickory, North Carolina, United States
New Bern Cancer Care
New Bern, North Carolina, United States
James Cancer Hospital
Columbus, Ohio, United States
SouthWest Regional Cancer Center
Austin, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Frankston Hospital
Frankston, , Australia
HOCA
South Brisbane, , Australia
Border Medical Oncology
Wodonga, , Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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CC-5013-NHL-005
Identifier Type: -
Identifier Source: org_study_id
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