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
Brief 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.
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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