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

Stopped early · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Key facts

Study ID

NCT00474188

Run by

Celgene Corporation

People needed

26

Starts

2007-05-01

Expected to finish

2008-12-01

Last updated by the study team

2009-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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