Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      This research study is for patients with newly diagnosed Diffuse Large B-cell Lymphoma
      (DLBCL) of the activated B-cell (ABC) type who have not yet been treated. DLBCL is a cancer
      of a type of blood cell called B-lymphocytes. B lymphocytes are part of the body's immune
      system. There are different types of DLBCL. About a third of newly diagnosed DLBCL cancers
      are the ABC type. It has been observed that treatment does not work as well for patients with
      the ABC type compared to patients with other DLBCL types who receive standard treatment.
      However, at this time both ABC type and other DLBCL type patients receive the same standard
      treatments.

      Patients with DLBCL who are otherwise healthy are usually treated first with the chemotherapy
      drug combination called R-CHOP. The drugs in this combination are "R" for rituximab, "C" for
      cyclophosphamide, "H" for doxorubicin which has a chemical name of hydroxydaunomycin, "O" for
      vincristine which has a trade name of oncovin, and "P" for prednisone. Depending on the local
      practice where you are treated, R-CHOP may be given for 6 or 8 cycles. A cycle could lasts
      for 14 or 21 days. The R-CHOP drug combination is approved for the treatment of DLBCL of all
      types, including ABC type. R-CHOP is standard care.

      This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is
      to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This
      study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is
      not approved for use in DLBCL. Its use in this disease is experimental. In this study, the
      experimental treatment is lenalidomide + R-CHOP21 x 6.

      This study will use a gene expression profile (GEP) test to see if a patient has the ABC
      type. The results of this GEP test affect whether you may be treated on this study. Because
      the performance of this test has not been proven, it is for investigational use only, and is
      still under development. This means the GEP test is an experimental test.
    

Intervention name(s): lenalidomide; Placebo; Rituximab; Cyclophosphamide; Doxorubicin; prednisone; vincristine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: R-CHOP chemotherapy; DLBCL front line therapy; gene expression profiling (GEP) activated B-cell (ABC) type DLBCL biomarkers; Activated B-Cell (ABC) type; Diffuse Large B-Cell Lymphoma, not otherwise specified; Diffuse Large B-Cell Lymphoma, associated with chronic inflammation; Diffuse Large B-Cell Lymphoma, Epstein-Barr virus positive (EBS+) of the elderly; Diffuse Large B-Cell Lymphoma, T-cell / histiocyte-rich