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13NHL-14-3: 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

Description

This randomized, placebo controlled study is designed to evaluate the efficacy and safety of R2-CHOP chemotherapy versus placebo-R-CHOP chemotherapy in previously untreated ABC typeDiffuse Large B-Cell Lymphoma (DLBCL). The study is divided into the Screening Period, Treatment Period, and Follow-up Period. There is biological possibility and also preclinical data that provide strong support for whylenalidomide should be expected to enhance the efficacy of the current standard of care R-CHOP in the treatment of the ABC type of DLBCL. Lenalidomide suppresses the proliferation of ABCcells in DLBCLand delays tumor growth in a human mouse model. In addition, studies also show enhancement of antibody dependent cell toxicity to cancer cells. Primary objective is 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 subjects who have previously untreated ABC type Diffuse Large B-Cell Lymphoma.Participants will receive protocol specified treatments for 6 cycles. Study treatments in a 21-day cycle are: lenalidomide / placebo Days 1 14; rituximab, cyclophosphamide, doxorubicin, and vincristine Day 1; prednisone Days 1 5Primary Endpoint is Progression-free Survival.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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)

  • 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

Sites

Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.

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