SHS_492290 PAGJ CCLG 15199

Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Inclusion Criteria:
Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ? 1; and each organ system score ? 2 using cumulative illness rating scale (CIRS).

Exclusion Criteria:
Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV). Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2.
Phase III
Cancer, All Other
John Pagel, M.D.
Celgene Corporation
Neil Bailey
  • Swedish Medical Center