Clinical Trials

Phase 3 Randomized, Double-blind, Placebo Controlled, Multicenter Study to Compare the Efficacy & Safety of Lenalidomide Plus R-CHOP Chemotherapy (R2-CHOP) versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated Activated B-Cell (ABC) Type Diffuse Large B-Cell Lymphoma (DLBCL). (The “ROBUST” Study)

Study Title

Phase 3 Randomized, Double-blind, Placebo Controlled, Multicenter Study to Compare the Efficacy & Safety of Lenalidomide Plus R-CHOP Chemotherapy (R2-CHOP) versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated Activated B-Cell (ABC) Type Diffuse Large B-Cell Lymphoma (DLBCL). (The “ROBUST” Study)

Purpose

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

Eligibility

Diagnosed Activated B-Cell type Diffuse Large B-Cell Lymphoma                        

Between the ages of 18-80 years old                         Measurable disease on CT scan

Ann Arbor stage II-IV disease

No prior treatment for DLBCL

International Prognostic Index score of 2 or greater

ECOG performance status ≤ 2

You Cannot:           

Have composite DLBCL & Follicular Lymphoma, or transformed Non-Hodgkin’s Lymphoma

Have Hepatitis B or C

Have a life expectancy of less than 6 months

Have a history of other malignancies, unless disease free for ≥ 5 years

Prior use of lenalidomide

Study Process

The study is divided into the Screening Period, Treatment Period, & Follow-up Period.  

Screening Period- determines eligibility to participate      

Treatment Period- involves up to 6 cycles of treatment depending upon treatment response

Follow-up Period- begins immediately after treatment ends & continues until disease progression, change in treatment, development of any second cancer, & overall survival

Interested in more information on this clinical research study?

Contact WK Cancer Center Clinical Research Department at 318-212-8671